Apparatus and method for measuring biologic parameters

ABSTRACT

Support structures for positioning sensors on a physiologic tunnel for measuring physical, chemical and biological parameters of the body and to produce an action according to the measured value of the parameters. A sensor fitted on the support structures uses a special geometry for acquiring continuous and undisturbed data on the physiology of the body. Signals are transmitted to a remote station by wireless transmission such as by electromagnetic waves, radio waves, infrared, sound and the like or by being reported locally by audio or visual transmission. The physical and chemical parameters include brain function, metabolic function, hydrodynamic function, hydration status, levels of chemical compounds in the blood, and the like. The support structure includes patches, clips, eyeglasses, head mounted gear and the like, containing passive or active sensors positioned at the end of the tunnel with sensing systems positioned on and accessing a physiologic tunnel.

This application is a complete application of provisional applicationNos. 60/729,232 and 60/802,503, filed on Oct. 24, 2005 and May 23, 2006,respectively, and is a continuation-in-part of U.S. patent applicationSer. No. 10/786,623, filed Feb. 26, 2004, which is acontinuation-in-part of U.S. Ser. No. 10/420,295, filed Apr. 22, 2003,now U.S. Pat. No. 7,187,960.

FIELD OF THE INVENTION

The present invention includes support and sensing structures positionedin a physiologic tunnel for measuring bodily functions and to manageabnormal conditions indicated by the measurements.

BACKGROUND OF THE INVENTION

Interfering constituents and variables can introduce significant sourceof errors that prevent measured biologic parameters from being ofclinical value. In order to bypass said interfering constituents andachieve undisturbed signals, invasive and semi-invasive techniques havebeen used. Such techniques have many drawbacks including difficulties inproviding continuous monitoring for long periods of time. Non-invasivetechniques also failed to deliver the clinical usefulness needed. Theplacement of a sensor on the skin characterized by the presence ofinterfering constituents do not allow obtaining clinically useful noraccurate signals due to the presence of said interfering constituentsand background noise which greatly exceeds the signal related to thephysiologic parameter being measured.

The most precise, accurate, and clinically useful way of evaluatingthermal status of the body in humans and animals is by measuring braintemperature. Brain temperature measurement is the key and universalindicator of both disease and health equally, and is the only vital signthat cannot be artificially changed by emotional states. The other vitalsigns (heart rate, blood pressure, and respiratory rate) all can beinfluenced and artificially changed by emotional states or voluntaryeffort.

Body temperature is determined by the temperature of blood, which emitsheat as far-infrared radiation. Adipose tissue (fat tissue) absorbsfar-infrared and the body is virtually completely protected with a layerof adipose tissue adherent to the skin. Thus measurement of temperatureusing the skin did not achieve precision nor accuracy because previoustechniques used sensors placed on skin characterized by the presence ofadipose tissue.

Because it appeared to be impossible with current technology tonon-invasively measure brain temperature, attempts were made todetermine internal body temperature, also referred to as coretemperature. An invasive, artificial, inconvenient, and costly processis currently used to measure internal (core) temperature consisting ofinserting a catheter with a temperature sensor in the urinary canal,rectum or esophagus. But such methodology is not suitable for routinemeasurement, it is painful, and has potential fatal complications.

Semi-invasive techniques have also being tried. Abreu disclosed in U.S.Pat. No. 6,120,460 apparatus and methods for measuring core temperaturecontinuously using a contact lens in the eyelid pocket, but the contactlens is a semi-invasive device which requires prescription by aphysician and sometimes it is not easy to place the contact lens in theeye of an infant or even in adults and many people are afraid oftouching their eyes.

There are several drawbacks and limitations in the prior art forcontinuous and/or core measurement of temperature.

Measurement of temperature today is non-continuous, non-core and nursedependent. Nurses have to stick a thermometer in the patient's mouth,rectum or ear. To get core temperature nurses invasively place a tubeinside the body which can cause infection and costly complications.

Measurement of core temperature on a routine basis in the hospitaland/or continuously is very difficult and risky because it requires aninvasive procedure with insertion of tubes inside the body or byingesting a thermometer pill. The thermometer pill can cause diarrhea,measure temperature of the fluid/food ingested and not body temperature,and have fatal complications if the pill obstructs the pancreas or liverducts. Placement of sensors on the skin do not provide clinically usefulmeasurements because of the presence of many interfering constituentsincluding fat tissue.

It is not possible to acquire precise and clinically useful measurementsof not only brain temperature, but also metabolic parameters, physicalparameters, chemical parameters, and the like by simply placing a sensoron the skin. One key element is the presence of fat tissue. Fat variesfrom person to person, fat varies with aging, fat content varies fromtime to time in the same person, fat attenuates a signal coming from ablood vessel, fat absorbs heat, fat prevents delivery of undisturbedfar-infrared radiation, fat increases the distance traveled by theelement being measured inside the body and an external sensor placed onthe surface of the skin.

There is a need to identify a method and apparatus that cannon-invasively, conveniently and continuously monitor brain temperaturein a painless, simple, external and safe manner with sensors placed onthe skin.

There is further a need to identify a method and apparatus that canconveniently, non-invasively, safely and precisely monitor biologicalparameters including metabolic parameters, physical parameters, chemicalparameters, and the like.

There is a need to identify an apparatus and method capable of measuringbiological parameters by positioning a sensor on a physiologic tunnelfor the acquisition of undisturbed and continuous biological signals.

SUMMARY OF THE INVENTION

The present invention provides methods, apparatus and systems thateffectively address the needs of the prior art.

In general, the invention provides a set of sensing systems andreporting means which may be used individually or in combination, whichare designed to access a physiologic tunnel to measure biological,physical and chemical parameters. Anatomically and physiologicallyspeaking, the tunnel discovered by the present invention is an anatomicpath which conveys undisturbed physiologic signals to the exterior. Thetunnel consists of a direct and undisturbed connection between thesource of the function (signal) within the body and an external point atthe end of the tunnel located on the skin. A physiologic tunnel conveyscontinuous and integral data on the physiology of the body. Anundisturbed signal from within the body is delivered to an externalpoint at the end of the tunnel. A sensor placed on the skin at the endof the tunnel allows optimal signal acquisition without interferingconstituents and sources of error.

Included in the present invention are support structures for positioninga sensor on the skin at the end of the tunnel. The present inventiondiscloses devices directed at measuring brain temperature, brainfunction, metabolic function, hydrodynamic function, hydration status,hemodynamic function, body chemistry and the like. The componentsinclude devices and methods for evaluating biological parameters usingpatches, clips, eyeglasses, head mounted gear and the like with sensingsystems adapted to access physiologic tunnels to provide precise andclinically useful information about the physiologic status of the wearerand for enhancing the safety and performance of said wearer, and helpingto enhance and preserve the life of said wearer by providing adequatereporting means and alert means relating to the biological parameterbeing monitored. Other components provide for producing direct orindirect actions, acting on another device, or adjusting another deviceor article of manufacture based on the biological parameter measured.

The search for a better way to measure biological parameters hasresulted in long and careful research, which included the discovery of aBrain Temperature Tunnel (BTT) and other physiologic tunnels in humansand animals. The present invention was the first to recognize thephysiologic tunnel in the body. The present invention was yet the firstto recognize the end of the tunnel on the skin surface in which anoptimal signal is acquired and measurements can be done without thepresence of interfering constituents and background noise that exceedsthe signal being measured. The present invention was also the first torecognize and precisely map the special geometry and location of thetunnel including the main entry point. The present invention was yetfirst to recognize the precise positioning of sensing systems at themain entry point for optimal signal acquisition. Careful studies havebeen undertaken including software development for characterizinginfrared radiation to precisely determine the different aspects of thetunnel. This research has determined that the measurement of brain(core) temperature and other body parameters can be accomplished in anon-invasive and continuous manner in humans and animals with sensorspositioned in a confined area of the skin at the end of a physiologictunnel.

The key function and critical factor for life preservation and humanperformance is brain temperature. Brain tissue is the tissue in the bodymost susceptible to thermal damage, by both high and low temperature.Brain temperature is the most clinically relevant parameter to determinethe thermal status of the body and the human brain is responsible for 18to 20% of the heat produced in the body, which is an extraordinary factconsidering that the brain represents only 2% of the body weight. Thegreat amount of thermal energy generated in the brain is kept in aconfined space and the scalp, skull, fat and CSF (cerebral spinal fluid)form an insulating layer. The recognition of the BTT by the presentinvention bypasses the insulating barriers and provides a directconnection to inside the brain physiology and physics.

Anatomically and physiologically speaking, a Brain Temperature Tunnelconsists of a continuous, direct, and undisturbed connection between theheat source within the brain and an external point at the end of thetunnel. The physical and physiological events at one end of the tunnelinside the brain are reproduced at the opposite end on the skin. A BTTenables the integral and direct heat transfer through the tunnel withoutinterference by heat absorbing elements, i.e., elements that can absorbfar-infrared radiation transmitted as heat by blood within the brain.There are six characteristics needed to define a BTT. Thesecharacteristics are:

-   -   1) area without heat absorbing elements, i.e., the area must not        contain adipose tissue (fat tissue). This is a key and needed        characteristic for defining a temperature tunnel,    -   2) area must have a terminal branch of a vessel in order to        deliver the integral amount of heat,    -   3) terminal branch has to be a direct branch of a blood vessel        from the brain,    -   4) terminal branch has to be superficially located to avoid heat        absorption by deep structures such as muscles,    -   5) area must have a thin and negligible interface between a        sensor and the source of thermal energy to achieve high heat        flow, and    -   6) area must not have thermoregulatory arteriovenous shunts.        All six characteristics are present on the skin on the medial        canthal area adjacent to the medial corner of the eye above the        medial canthal tendon and in the medial third of the upper        eyelid. In more detail the end of BTT area on the skin measures        about 11 mm in diameter measured from the medial corner of the        eye at the medial canthal tendon and extends superiorly for        about 6 mm and then extends into the upper eyelid in a horn like        projection for another 22 mm.

The BTT area is the only area in the body without adipose tissue, whichis in addition supplied by a terminal branch, which has a superficialblood vessel coming from the brain vasculature, and which has a thininterface and no thermoregulatory shunts. The BTT area is supplied by aterminal branch of the superior ophthalmic vein which is a directconnection to the cavernous sinus, said cavernous sinus being anendothelium-lined system of venous channels inside the brain whichcollects and stores thermal energy. The blood vessel supplying the BTTarea is void of thermoregulatory arteriovenous shunts and it ends on theskin adjacent to the medial corner of the eye and in the superior aspectof the medial canthal area right at the beginning of the upper eyelid.The blood vessels deliver undisturbed heat to the skin on the medialcanthal area and upper eyelid as can be seen in the color as well asblack and white photos of infrared images shown in FIGS. 1 and 2. Theundisturbed thermal radiation from the brain is delivered to the surfaceof the skin at the end of the tunnel. The heat is delivered to an areaof skin without fat located at the end of the tunnel. The blood vesseldelivering heat is located just below the skin and thus there is noabsorption of infrared radiation by deep structures.

If the blood vessel is located deep, other tissues and chemicalsubstances would absorb the heat, and that can invalidate the clinicalusefulness of the measurement. There is direct heat transfer and theskin in the BTT area is the thinnest skin in the body and is void ofthermoregulatory arteriovenous shunts. A very important aspect foroptimal measurement of temperature is no interference by fat tissue anddirect heat transfer.

The absence of fat tissue in this particular and unique area in the bodyat the end of the tunnel allows the undisturbed acquisition of thesignal. The combination of those six elements allows the undisturbed andintegral emission of infrared radiation from the brain in the form ofdirect heat transfer at the BTT area location, which can be seen in theinfrared image photographs (FIGS. 1 to 8). The BTT and physiologictunnels are also referred in this description as the “Target Area”.

From a physical standpoint, the BTT is the equivalent of a Brain ThermalEnergy tunnel with high total radiant power and high heat flow. Thetemperature of the brain is determined by the balance between thermalenergy produced due to metabolic rate plus the thermal energy deliveredby the arterial supply to the brain minus the heat that is removed bycerebral blood flow. Convection of heat between tissue and capillariesis high and the temperature of the cerebral venous blood is inequilibrium with cerebral tissue. Accordingly, parenchymal temperatureand thermal energy of the brain can be evaluated by measuring thetemperature and thermal energy of the cerebral venous blood. Thesuperior ophthalmic vein has a direct and undisturbed connection to thecavernous sinus and carries cerebral venous blood with a thermal energycapacity of 3.6 J·ml⁻¹·(° C.)⁻¹ at hematocrit of 45%. Cerebralthermodynamic response, thermal energy, and brain temperature can beevaluated by placing a sensor to capture thermal energy conveyed by thecerebral venous blood at the end of the BTT.

The research concerning BTT and physiologic tunnels involved variousactivities and studies including: 1) In-vitro histologic analysis ofmucosal and superficial body areas; 2) In-vivo studies with temperatureevaluation of external areas in humans and animals; 3) In-vivofunctional angiographic evaluation of heat source; 4) Morphologicstudies of the histomorphometric features of the BTT area; 5) In-vivoevaluation of temperature in the BTT area using: thermocouples,thermistors, and far-infrared; 6) Comparison of the BTT areameasurements with the internal eye anatomy and current standard mostused (oral) for temperature measurement; 7) Cold and heat challenge todetermine temperature stability of BTT; and 8) Infrared imaging andisotherm determination. Software for evaluating geometry of tunnel wasalso developed and used. Simultaneous measurement of a referencetemperature and temperature in the BTT area were done using pre-equallycalibrated thermistors. A specific circuit with multiple channels wasdesigned for the experiments and data collection.

The measurement of temperature in the BTT area showed almost identicaltemperature signal between the BTT area and the internal conjunctivalanatomy of the eye, which is a continuation of the central nervoussystem. Measurement of the temperature in the internal conjunctivalanatomy of eye as used in the experiment was described by Abreu in U.S.Pat. Nos. 6,120,460 and 6,312,393. The averaged temperature levels forBTT and internal eye were within 0.1° C. (0.18° F.) with an averagenormothermia value equivalent of 37.1° C. (98.8° F.) for the BTT and 37°C. (98.6° F.) for the internal eye. Comparison with the standard mostused, oral temperature, was also performed. The temperature voltagesignal of the BTT area showed an average higher temperature level in theBTT area of an equivalent of 0.3° C. (0.5° F.) when compared to oral.

Subjects underwent cold challenge and heat challenge through exercisingand heat room. The lowering and rising of temperature in the BTT areawas proportional to the lowering and rising in the oral cavity. However,the rate of temperature change was faster in the BTT area than for oralby about 1.2 minutes, and temperature at the BTT site was 0.5° C. (0.9°F.) higher on few occasions. Subjects of different race, gender, and agewere evaluated to determine the precise location of the BTT area acrossa different population and identify any anatomic variation. The locationof the BTT was present at the same location in all subjects with nosignificant anatomic variation, which can be seen in a sample ofinfrared imaging of different subjects.

The tunnel is located in a crowded anatomic area and thus thepositioning of the sensor requires special geometry for optimalalignment with the end of the tunnel. The clinical usefulness of thetunnel can only be achieved with the special positioning of the sensorin relation to anatomic landmarks and the support structure. The tunnelis located in a unique position with distinctive anatomic landmarks thathelp define the external geometry and location of the end of the tunnel.The main entry point of the tunnel, which is the preferred location forpositioning the sensor, requires the sensor to be preferably placed inthe outer edge of a support structure. The preferred embodiment for themeasurement of biological parameters by accessing a physiologic tunnelincludes sensors positioned in a particular geometric position on thesupport structure.

The support structure includes patches containing sensors. For thepurpose of the description any structure containing an adhesive as meansto secure said structure to the skin at the end of the tunnel isreferred to as a patch including strips with adhesive surfaces such as a“BAND-AID” adhesive bandage. It is understood that a variety ofattachment means can be used including adhesives, designs incorporatingspring tension pressure attachment, and designs based on otherattachment methods such as elastic, rubber, jelly-pads and the like.

The patches are adapted to position sensors at the end of the tunnel foroptimal acquisition of the signal. The patch is preferably secured tothe area by having an adhesive backing which lays against the skin,although a combination of adhesive and other means for creating a stableapposition of the sensor to the tunnel can be used such as fastening orpressure.

Support structures also include clips or structures that are positionedat the end of the tunnel with or without adhesive and which are securedto the area by pressure means. Any structure that uses pressure means tosecure said structure to the skin at the end of the tunnel is referredas a clip.

Head-mounted structures are structures mounted on the head or neck forpositioning sensors on the end of the tunnel and include headbands withaccessories that are adjacent to the tunnel, visors, helmets, headphone,structures wrapping around the ear and the like. For the purpose of thisdescription TempAlert is referred herein as a system that measurestemperature in the BTT area and has means to report the measured valueand that can incorporate alarm devices that are activated when certainlevels are reached. Support structures yet include any article that hassensing devices in which said sensing devices are positioned at the endof the tunnel.

Support structures further include medial canthal pieces of eyeglasses.A medial canthal piece is also referred to herein as a medial canthalpad and includes a pad or a piece which positions sensing devices on theskin at the medial canthal area on top of a tunnel, with said medialcanthal piece being permanently attached to or mounted to an eyeglass.Any sensing devices incorporated in an eyeglass (fixed or removable) foraccessing a tunnel are referred to herein as EyEXT including devices forsensing physical and chemical parameters. Any article of manufacturethat has visual function, or ocular protection, or face protection witha part in contact with the tunnel is referred herein as eyeglasses andincludes conventional eyeglasses, prescription eyeglasses, readingglasses, sunglasses, goggles of any type, masks (including gas masks,surgical masks, cloth masks, diving masks, eyemask for sleeping and thelike) safety glasses, and the like.

For brain temperature evaluation the tunnel area consists of the medialcanthal area and the superior aspect of the medial corner of the eye.For brain function evaluation the tunnel area consists of primarily theupper eyelid area. For metabolic function evaluation the tunnel areaconsists of an area adjacent to the medial corner of the eye and boththe upper and lower eyelids.

The measurement of metabolic function, brain function, immunogenicfunction, physical parameters, physico-chemical parameters and the likeincludes a variety of support structures with sensors accessing thephysiologic tunnels. The sensors are placed in apposition to the skinimmediately adjacent to the medial corner of the eye preferably in thesuperior aspect of the medial canthal area. The sensor can also bepositioned in the medial third of the upper eyelid. The sensor is mostpreferably located at the main entry point of the tunnel which islocated on the skin 2.5 mm medial to the corner of the eye and about 3mm above the medial corner of the eye. The diameter of the main entrypoint is about 6 to 7 mm. The positioning of the sensor at the mainentry point of the tunnel provides the optimum site for measuringphysical and chemical parameters of the body.

Besides a sensor that makes contact with the skin at the Target Area, itis understood that sensors which do not make contact with the skin canbe equally used. For instance an infrared-based temperature measuringsystem can be used. The measurement is based on the Stefan-Boltzman lawof physics in which the total radiation is proportional to the fourthpower of the absolute temperature, and the Wien Displacement law inwhich the product of the peak wavelength and the temperature areconstant. The field of view of the non-contact infrared apparatus of theinvention is adapted to match the size and geometry of the BTT area onthe skin.

A variety of lenses known in the art can be used for achieving the fieldof view needed for the application. For example, but not by way oflimitation, a thermopile can be adapted and positioned in a manner tohave a field of view aimed at the main entry point of the BTT area onthe skin. The signal is then amplified, converted into a voltage outputand digitized by a MCU (microcontroller).

This infrared-based system can be integrated into a support structurethat is in contact with the body such as any of the support structuresof the present invention. In addition, it is understood that theinfrared-based system of the present invention can be integrated as aportable or hand-held unit completely disconnected from the body. Theapparatus of the present invention can be held by an operator that aimssaid apparatus at the BTT area to perform the measurement. The apparatusfurther includes an extension shaped to be comfortably positioned at theBTT site for measuring biological parameters without discomfort to thesubject. The extension in contact with the skin at the BTT is shaped inaccordance with the anatomic landmarks and the geometry and size of theBTT site. The infrared radiation sensor is positioned in the extensionin contact with the skin for receiving radiation emitted from the BTTsite.

The present invention provides a method for measuring biologicalparameters including the steps of positioning a sensing device means onthe skin area at the end of a tunnel, producing a signal correspondingto the biological parameter measured and reporting the value of theparameter measured.

It is also includes a method to measure biological parameters bynon-contact infrared thermometry comprising the steps of positioning aninfrared detector at the BTT site with a field of view that encompassesthe BTT site and producing a signal corresponding to the measuredinfrared radiation. The biological parameters include temperature, bloodchemistry, metabolic function and the like.

Temperature and ability to do chemical analysis of blood components isproportional to blood perfusion. The present invention recognizes thatthe tunnel area, herein also referred as a Target Area, has the highestsuperficial blood perfusion in the head and has a direct communicationwith the brain, and that the blood vessels are direct branches of thecerebral vasculature and void of thermoregulatory arteriovenous shunts.It was also recognized that the Target Area has the highest temperaturein the surface of the body as can be seen in the photographs ofexperiments measuring infrared emission from the body and the eye.

The Target Area discovered not only has the thinnest and mosthomogeneous skin in the whole body but is the only skin area without afat layer. Since fat absorbs significant amounts of radiation, there isa significant reduction of signal. Furthermore other skin areas onlyprovide imprecise and inaccurate signals because of the large variationof adipose tissue from person to person and also great variability offat tissue according to age. This interference by a fat layer does notoccur in the Target Area. Furthermore, the combined characteristics ofthe Target Area, contrary to the skin in the rest of the body, enablethe acquisition of accurate signals and a good signal to noise ratiowhich far exceeds background noise. In addition, body temperature suchas is found in the surface of the skin in other parts of the body isvariable according to the environment.

Another important discovery of the present invention was thedemonstration that the Target Area is not affected by changes in theenvironment (experiments included cold and heat challenge). The TargetArea provides an optimum location for temperature measurement which hasa stable temperature and which is resistant to ambient conditions. TheTarget Area discovered has a direct connection to the brain, is notaffected by the environment and provides a natural, complete thermalseal and stable core temperature. The apparatus and methods of thepresent invention achieve precision and clinical usefulness needed withthe non-invasive placement of a temperature sensor on the skin in directcontact with the heat source from the brain without the interference ofheat absorbing elements.

The Target Area is extremely vascularized and is the only skin area inwhich a direct branch of the cerebral vasculature is superficiallylocated and covered by a thin skin without a fat layer. The main trunkof the terminal branch of the ophthalmic vein is located right at theBTT area and just above the medial canthal tendon supplied by the medialpalpebral artery and medial orbital vein. The BTT area on the skinsupplied by a terminal and superficial blood vessel ending in aparticular area without fat and void of thermoregulatory arteriovenousshunts provides a superficial source of undisturbed biological signalsincluding brain temperature, metabolic function, physical signals, andbody chemistry such as glucose level, and the like.

Infrared spectroscopy is a technique based on the absorption of infraredradiation by substances with the identification of said substancesaccording to its unique molecular oscillatory pattern depicted asspecific resonance absorption peaks in the infrared region of theelectromagnetic spectrum. Each chemical substance absorbs infraredradiation in a unique manner and has its own unique absorption spectradepending on its atomic and molecular arrangement and vibrational androtational oscillatory pattern. This unique absorption spectra allowseach chemical substance to basically have its own infrared spectrum,also referred to as fingerprint or signature which can be used toidentify each of such substances. Radiation containing various infraredwavelengths is emitted at the substance to be measured and the amount ofabsorption of radiation is dependent upon the concentration of saidchemical substance being measured according to Beer-Lambert's Law.

Interfering constituents and variables such as fat, bone, muscle,ligaments and cartilage introduce significant source of errors which areparticularly critical since the background noise greatly exceeds thesignal of the substance of interest. Since those interferingconstituents are not present on the skin at the BTT area, the sensingsystems positioned at said BTT area can acquire optimal signal withminimal noise including spectroscopic-based measurements.

Spectroscopic devices integrated into support structures disclosed inthe present invention can precisely non-invasively measure bloodcomponents since the main sources of variation and error, such as fattissue, are not present in the Target Area. In addition, other keyconstituents which interfere with electromagnetic energy emission suchas muscle, cartilage and bones, are not present in the Target Areaeither. The blood vessels delivering the infrared radiation aresuperficially located and the infrared radiation is delivered at the endof the tunnel without interacting with other structures. The onlystructure to be traversed by the infrared radiation is a very thin skin,which does not absorb the infrared wavelength. The present inventionincludes infrared spectroscopy means to provide a clinically usefulmeasurement with the precise and accurate determination of theconcentration of the blood components at the end of the tunnel.

In addition to spectroscopy in which electromagnetic energy is deliveredto the Target Area, the present invention also discloses apparatus andmethods for measuring substances of interest through far infraredthermal emission from the Target Area. Yet, besides near-infraredspectroscopy and thermal emission, other devices are disclosed formeasurement of substances of interest at the Target Area includingelectroosmosis as a flux enhancement by iontophoresis or reverseiontophoresis with increased passage of fluid through the skin throughapplication of electrical energy. Yet, transcutaneous optical devicescan also be integrated into support structures including medial canthalpieces, modified nose pads, and the frame of eyeglasses, with saiddevices positioned to access the tunnel.

It is understood that application of current, ultrasonic waves as wellas chemical enhancers of flow, electroporation and other devices can beused to increase permeation at the tunnel site such as for exampleincreased flow of glucose with the use of alkali salts. In additioncreating micro holes in the target area with a laser, or other meansthat penetrate the skin can be done with the subsequent placement ofsensing devices on the BTT site, with said devices capable of measuringchemical compounds. Furthermore, reservoirs mounted on or disposedwithin support structures, such as the frame and pads of eyeglasses, candeliver substances transdermally at the BTT site by various devicesincluding iontophoresis, sonophoresis, electrocompression,electroporation, chemical or physical permeation enhancers, hydrostaticpressure and the like.

In addition to measure the actual amount of oxygen in blood, the presentinvention also discloses devices to measure oxygen saturation and theamount of oxygenated hemoglobin. In this embodiment the medial canthalpiece of a support structure or the modified nose pads of eyeglassescontain LEDs emitting at two wave lengths around 940 and 660 nanometers.As the blood oxygenation changes, the ratio of the light transmitted bythe two frequencies changes indicating the oxygen saturation. Since theblood level is measured at the end of a physiologic brain tunnel, theamount of oxygenated hemoglobin in the arterial blood of the brain ismeasured, which is the most valuable and key parameter for athleticpurposes and health monitoring.

The present invention also provides a method for measuring biologicalparameters with said method including the steps of directingelectromagnetic radiation at the BTT area on the skin, producing asignal corresponding to the resulting radiation and converting thesignal into a value of the biological parameter measured.

Besides using passive radio transmission or communication by cable;active radio transmission with active transmitters containing amicrominiature battery mounted in the support structure can also beused. Passive transmitters act from energy supplied to it from anexternal source. The transensor transmits signals to remote locationsusing different frequencies indicative of the levels of biologicalparameters. Ultrasonic micro-circuits can also be mounted in the supportstructure and modulated by sensors which are capable of detectingchemical and physical changes at the Target Area. The signal may betransmitted using modulated sound signals particularly under waterbecause sound is less attenuated by water than are radio waves.

One preferred embodiment comprises a support structure including a patchadapted to be worn on or attached with adhesives to the tunnel andincludes structural support, a sensor for measuring biologicalparameters, power source, microcontroller and transmitter. The parts canbe incorporated into one system or work as individual units. The sensoris located preferably within 7 mm from the outer edge of the patch. Theapparatus of the invention can include a temperature sensor located inthe outer edge of the patch for sensing temperature. The transmitter,power source and other components can be of any size and can be placedin any part of the patch or can be connected to the patch as long as thesensing part is placed on the edge of the patch in accordance with theprinciples of the invention. The sensor in the patch is positioned onthe skin adjacent to the medial canthal area (medial corner of the eye)and located about 2 mm from the medial canthal tendon. The sensor canpreferably include electrically-based sensors, but non-electricalsystems can be used such as chemicals that respond to changes intemperature including mylar.

Besides patches, another preferred embodiment for measuring biologicalparameters at the physiologic tunnel includes a medial canthal pad. Themedial canthal piece is a specialized structure containing sensors foraccessing the tunnel and adapted to be worn on or attached to eyeglassesin apposition to the tunnel and includes structural support, a sensorfor measuring biological parameters, power source, microcontroller andtransmitter. The parts can be incorporated into one system or work asindividual units. The sensors are positioned on the BTT area. Thetransmitter, power source, and other components can be placed in themedial canthal pad or in any part of the eyeglasses. A medial canthalpiece or extension of nose pads of eyeglasses allow accessing thephysiologic tunnel with sensing devices laying in apposition to the BTTarea.

The apparatus of the invention include a temperature sensor located inthe medial canthal pad. For temperature measurement the sensing systemis located on a skin area that includes the medial canthal corner of theeye and upper eyelid. The sensor in the medial canthal pad is preferablypositioned on the skin adjacent to the medial canthal area (medialcorner of the eye). Although one of the preferred embodiments formeasurement of brain temperature consists of medial canthal pads, it isunderstood that also included in the scope of the invention are nosepads of a geometry and size that reach the tunnel and that are equippedwith temperature sensors preferably in the outer edge of said nose padsfor measuring brain temperature and other functions. An oversized andmodified nose pad containing sensors using a special geometry foradequate positioning at the BTT area is also included in the invention.

With the disclosure of the present invention and by using anatomiclandmarks in accordance with the invention the sensor can be preciselypositioned on the skin at the end of the tunnel. However, since there isno external visible indication on the skin relating to the size orgeometry of the tunnel, accessory means can be used to visualize, map ormeasure the end of the tunnel on the skin. These accessory means may beparticularly useful for fitting medial canthal pads or modified nosepads of eyeglasses.

Accordingly, an infrared detector using thermocouple or thermopiles canbe used as an accessory for identifying the point of maximum thermalemission and to map the area. An infrared imaging system or thermographysystem may be preferably used. In this instance, an optical storeselling the eyeglasses can have a thermal imaging system. The optician,technician and the like take an infrared image picture or film the area,and in real time localize the tunnel of the particular user. The medialcanthal pads or modified nose pads can then be adjusted to fit theparticular user based on the thermal infrared imaging. The eyeglassesare fitted based on the thermal image created. This will allowcustomized fitting according to the individual needs of the user. Anythermography-based system can be used including some with great visualimpact and resolution as a tri-dimensional color thermal wave imaging.

It is also a feature of the invention to provide a method to be used forexample in optical stores for locating the tunnel including the steps ofmeasuring thermal infrared emission, producing an image based on theinfrared emission, and detecting the area with the highest amount ofinfrared emission. Another step that can be included is adjustingsensors in support structures to match the area of highest infraredemission.

One of said support structures includes the medial canthal pieces ornose pads of eyeglasses. The thermal imaging method can be used forfitting a patch, but said patch can be positioned at the tunnel byhaving an external indicator for lining up said indicator with apermanent anatomic landmark such as the medial corner of the eye.Although medial canthal pieces of eyeglasses can have an externalindicator for precise positioning, since opticians are used to fiteyeglasses according to the anatomy of the user, the thermal imagingmethod can be a better fit for eyeglasses than an external indicator onthe medial canthal pieces or modified nose pads of eyeglasses.

The source of the signal is key for the clinical usefulness of themeasurement. The brain is the key and universal indicator of the healthstatus of the body. The signal coming from the brain or brain areaprovides the most clinically useful data. In accordance with anotherembodiment, the measurement of biological parameters will be described.The amount of sodium and other elements in sweat is a key factor forsafety and performance of athletes and military, as well as healthmonitoring.

For instance hyponatremia (decreased amount of sodium) can lead toreduced performance and even death. Hyponatremia can occur due to excesswater intake, commonly occurring with intense physical activity andmilitary training. Sweat can be considered as an ultrafiltrate of blood.The blood vessels supplying the skin on the head are branches of thecentral nervous system vasculature. The amount of chemical substancespresent in the sweat coming from those blood vessels is indicative ofthe amount of chemical substances present in the cerebral vasculature.For instance, sodium concentration of sweat from blood vessels in thehead changes in relation to the rates of sweating. The apparatus andmethods of the present invention can prevent death or harm due to waterintoxication, by providing alert signals when the levels of sodium insweat reach a certain threshold for that particular wearer. The presenceof various chemical elements, gases, electrolytes and pH of sweat andthe surface of the skin can be determined by the use of suitableelectrodes and suitable sensors integrated in the eyeglasses and othersupport structures mounted on the head or fitted on the head or face.These electrodes, preferably microelectrodes, can be sensitized byseveral reacting chemicals which are in the sweat or the surface of theskin. The different chemicals and substances can diffuse throughsuitable permeable membranes sensitizing suitable sensors.

For example but not by way of limitation, electrochemical sensors can beused to measure various analytes such as glucose using a glucose oxidasesensor and the pilocarpine iontophoresis method can be used to measureelectrolytes in sweat alone or in conjunction with microfluidics system.Besides the support structures of the present invention, it is alsounderstood that other articles such as watches, clothing, footwear andthe like can be adapted to measure concentration of substances such aselectrolytes present in sweat, however there is reduced clinicalrelevance for evaluating metabolic state of an individual outside thecentral nervous system.

Body abnormalities may cause a change in the pH, osmolarity, andtemperature of the sweat derived from brain and neck blood vessels aswell as change in the concentration of substances such as acid-lactic,glucose, lipids, hormones, gases, markers, infectious agents, antigens,antibody, enzymes, electrolytes such as sodium, potassium and chloride,and the like. Eyeglasses and any head gear can be adapted to measure theconcentration of substances in sweat. Microminiature glass electrodesmounted in the end portion of the temple of eyeglasses sitting behindthe ear or alternatively mounted on the lens rim against the foreheadcan be used to detect divalent cations such as calcium, as well assodium and potassium ion and pH. Chloride-ion detectors can be used todetect the salt concentration in the sweat and the surface of the skin.

Many agents including biological warfare agents and HIV virus arepresent in sweat and could be detected with the eyeglasses or supportstructure on the head or face using sensors coated with antibodiesagainst the agent which can create a photochemical reaction withappearance of colorimetric reaction and/or potential shift withsubsequent change in voltage or temperature that can be detected andtransmitted to a monitoring station or reported locally by audio orvisual means. Electrocatalytic antibodies also can generate anelectrical signal when there is an antigen-antibody interaction. It isalso understood that other articles such as watches, clothing, footwear,and the like or any article capturing sweat can be adapted to identifyantigens, antibody, infectious agents, markers (cancer, heart, genetic,metabolic, drugs, and the like) in accordance with the presentinvention. However, identification of those elements away from thecentral nervous system is of reduced clinical relevance.

The different amounts of fluid encountered in sweat can be easilyquantified and the concentration of substances calibrated according tothe amount of fluid in sweat. The relationship between the concentrationof chemical substances and molecules in the blood and the amount of saidchemical substances in the sweat can be described mathematically andprogrammed in a computer.

The present invention also includes eyeglasses or support structures inwhich a radio frequency transensor capable of measuring the negativeresistance of nerve fibers is mounted in the eyeglasses or supportstructure. By measuring the electrical resistance, the effects ofmicroorganisms, drugs, and poisons can be detected. The system alsocomprises eyeglasses in which a microminiature radiation-sensitivetransensor is mounted in said eyeglasses or support structure.

The brain has a rich vasculature and receives about 15% of the restingcardiac output and due to the absence of fat the tunnel offers an areafor optimal signal acquisition for evaluating hemodynamics. Accordingly,change in the viscosity of blood can be evaluated from a change indamping on a vibrating quartz micro-crystal mounted in the eyeglasses orsupport structure and the invention can be adapted to measure bloodpressure and to provide instantaneous and continuous monitoring of bloodpressure through an intact wall of a blood vessel from the brain and toevaluate hemodynamics and hydrodynamics. Also, by providing a contactmicrophone, arterial pressure can be measured using sonic devices.

Pressure can be applied to a blood vessel through a micro cuff mountedin the medial canthal pads, or alternatively by the temples ofeyeglasses. Pressure can also be applied by a rigid structure, and thepreferred end point is reached when sound related to blood turbulence isgenerated. The characteristic sound of systole (contraction of theheart) and diastole (relaxation of the heart) can be captured by themicrophone. A microphone integrated into the medial canthal pad can beadapted to identify the heart sounds. Pressure transducers such as acapacitive pressure transducer with integral electronics for signalprocessing and a microphone can be incorporated in the same siliconstructure and can be mounted in the medial canthal pad. Motion sensorsand/or pressure sensors can be mounted in the medial canthal pad tomeasure pulse.

Reversible mechanical expansion methods, photometric, or electrochemicalmethods and electrodes can be mounted in the eyeglasses or supportstructures of the present invention and used to detect acidity, gases,analyte concentration, and the like. Oxygen gas can also be evaluatedaccording to its magnetic properties or be analyzed bymicro-polarographic sensors mounted in the eyeglasses or other supportstructure. A microminiature microphone mounted in the eyeglasses orother support structure can also be adapted to detect sounds from theheart, respiration, flow, vocal and the environment, which can be sensedand transmitted to a remote receiver or reported by local audio andvisual means. The sensors are adapted and positioned to monitor thebiological parameters at the end of the tunnel.

The eyeglasses or other support structures can also have elements whichproduce and radiate recognizable signals and this procedure could beused to locate and track individuals, particularly in militaryoperations. A permanent magnet can also be mounted in the eyeglasses andused for tracking as described above. A fixed frequency transmitter canbe mounted in the eyeglasses and used as a tracking device whichutilizes a satellite tracking system by noting the frequency receivedfrom the fixed frequency transmitter to a passing satellite, or viaGlobal Positioning Systems. Motion and deceleration can be detected bymounting an accelerometer in the eyeglasses. The use of eyeglasses astracking devices can be useful for locating a kidnapped individual orfor rescue operations in the military, since eyeglasses are normallyunsuspecting articles.

The use of integrated circuits and advances occurring in transducer,power source, and signal processing technology allow for extrememiniaturization of the components which permits several sensors to bemounted in one unit.

The present invention provides continuous automated brain temperaturemonitoring without the need for a nurse. The present invention canidentify a spike in temperature. Thus, proper diagnosis is made andtherapy started in a timely fashion. Time is critical for identifyingthe temperature spike and organism causing the infection. Delay inidentifying spike and starting therapy for the infection can lead todemise of the patient. The invention timely and automatically identifiesthe temperature spike and prevents the occurrence of complications.

The present invention also alerts the user about overheating orhypothermia to allow:

-   -   1. Proper hydration;    -   2. Increased performance;    -   3. Increased safety; and    -   4. Feed back control in treadmills and other exercise machines        for keeping proper hydration and performance.

Annually many athletes, construction workers, college students and thegeneral public unnecessarily die due to heatstrokes. Once the brainreaches a certain temperature level such as 40° C., an almostirreversible process ensues. Because there are no specific symptoms andafter a certain point there is rapid increase in brain temperature,heatstroke has one of the highest fatality rates. The more severe andmore prolonged the episode, the worse the predicted outcome, especiallywhen cooling is delayed. Without measuring core temperature and havingan alert system when the temperature falls outside safe levels it isimpossible to prevent hyperthermia and heatstroke. The present inventionprovides a device for continuous monitoring of temperature with alertsystems that can prevent dangerous levels to be reached and coolingmeasures applied if needed. The apparatus can be adapted to be used inan unobtrusive manner by athletes, military, workers and the generalpopulation.

All chemical reactions in the body are dependent on temperature. Hightemperature can lead to enzymatic changes and protein denaturation andlow temperature can slow down vital chemical reactions. Hydration isdependent on brain temperature and loss of fluid leads to a rise inbrain temperature. Minimal fluctuations in the body's temperature canadversely affect performance and increase risk of illness and of lifethreatening events. Therefore, it is essential that athletes, sportsparticipants, military personnel, police officers, firefighters, forestrangers, factory workers, farmers, construction workers and otherprofessionals have precise mechanisms to know exactly what is theirbrain temperature.

When the core temperature rises, the blood that would otherwise beavailable for the muscles is used for cooling via respiration andperspiration. The body will do this automatically as temperature movesout of the preferred narrow range. It is this blood shifting thatultimately impairs physical performance and thermal induced damage tobrain tissue interferes with normal cognitive function. Intense exercisecan increase heat production in muscles 20 fold. In order to preventhyperthermia and death by heat stroke athletes drink water. Because theingestion of water is done in a random fashion, many times there iswater intoxication which can lead to death as occurs to many healthypeople including marathon runners and military personnel. Both, excessof water (overhydration) or lack of water (dehydration) can lead tofatal events besides reducing performance. Therefore, it is essentialthat individuals have precise means to know exactly when and how much todrink. By monitoring brain temperature with the present invention properhydration can be achieved and athletes and military will know preciselywhen and how much water to ingest.

Timely ingestion of fluids according to the core temperature allowsoptimization of cardiovascular function and avoidance of heat strain.Because there is a delay from the time of ingestion of fluid toabsorption of said fluid by the body, the method of invention includessignaling the need for ingestion at a lower core temperature such as38.5° C. to account for that delay, and thus avoid the onset ofexhaustion. The temperature threshold can be adjusted according to eachindividual, the physical activity, and the ambient temperature.

In addition, software can be produced based on data acquired at the BTTsite for optimizing fitness, athletic performance, and safety. The uppertemperature limit of a particular athlete for maintaining optimalperformance can be identified, and the data used to create software toguide said athlete during a competition. For instance, the athlete canbe informed on the need to drink cold fluid to prevent reaching acertain temperature level which was identified as reduced performancefor said athlete. Brain temperature level for optimal performanceidentified can be used to guide the effort of an athlete duringcompetition and training. Hyperthermia also affects mental performanceand software based on data from the BTT can be produced to optimizemental and physical performance of firefighters in an individual manner.People can have different thresholds for deleterious effects ofhyperthermia and thus setting one level for all users may lead tounderutilization of one's capabilities and putting others at risk ofreduced performance. Likewise, exercise endurance and mental performanceis markedly reduced by hypothermia and the same settings can be appliedfor low temperature situations. Determinations of brain temperature,oxygen and lactic acid levels can also be used for endurance training ofathletes, fitness training, and to monitor the effects of training. Thesystem, method, and apparatus of the invention provides a mechanism forenhancing safety and optimizing fitness for athletes and recreationalsports participants.

It is a feature of the invention to provide a method for the precise andtimely intake of fluids including the steps of measuring braintemperature, reporting the signal measured, and ingesting an amount offluid based on the signal measured. Other steps can be included such asreporting devices using voice reproduction or visual devices to instructon what beverage to drink and how much to drink to reduce coretemperature. It is understood that the method of the present inventioncan combine measurement of temperature associated with measurement ofsodium in sweat or blood, in accordance with the principles of theinvention.

Children do not tolerate heat as well as adults because their bodiesgenerate more heat relative to their size than adults do. Children arealso not as quick to adjust to changes in temperatures. In addition,children have more skin surface relative to their body size which meansthey lose more water through evaporation from the skin. It is understoodthat different sizes, shapes, and designs of medial canthal padsincluding children size can be used in the present invention. Childreneyeglasses equipped with sensors can have a booster radio transmitterthat will transmit the signal to a remote receiver and alert parentsabout dangerous temperature levels. The eyeglasses can be incorporatedwith a detecting system to send a signal if the eyeglasses were removedor if the temperature sensor is not capturing signals in a propermanner. By way of illustration, but not of limitation, pressure sensingdevices can be incorporated in the end of the temples to detect if thesunglasses are being worn, and an abrupt drop in the pressure signalindicates glasses were removed or misplacement of the sensor can alsogenerate an identifiable signal. An adhesive, a double-sided adhesivetape, or other devices for increasing grip can be used in the medialcanthal pads to ensure more stable position. It is understood that theeyeglasses can come equipped with sensors to detect ambient temperatureand humidity, which allows for precisely alerting the wearer about anyaspect affecting heat conditions.

In the current industrial, nuclear and military settings, personnel maybe required to wear protective clothing. Although the protectiveclothing prevent harm by hazardous agents, the garments increase therate of heat storage. It is understood that the present invention can becoupled with garments with adjustable permeability to automatically keepthe core temperature within safe limits.

In addition, the present invention alerts an individual about risk ofthermal damage (risk of wrinkles and cancer) at the beach or duringoutdoor activities. When one is at the beach, watching a game in astadium, camping or being exposed to the sun, the radiant energy of thesun is absorbed and transformed into thermal energy. The combination ofthe different ways of heat transfer to the body lead to an increase inbody temperature, which is reflected by the brain temperature.Convection and conduction can also lead to an increase in bodytemperature through heat transfer in the absence of sun light. Theabsorption of heat from the environment leads to a rise in the averagekinetic energy of the molecules with subsequent increase in coretemperature.

The levels of core temperature is related to the risk of thermal damageto the skin. After certain levels of heat there is an increased risk ofdenaturing protein and breaking of collagen in the skin. This can becompared with changes that occur when frying an egg. After a certainamount of thermal radiation is delivered the egg white changes fromfluidic and transparent to a hard and white structure. After the eggwhite reaches a certain level of temperature the structural changebecomes permanent. After a certain level of increase in core temperatureduring sun exposure, such as a level of 37.7° Celsius to 37.9° Celsiusat rest (e.g.; sun bathing), thermal damage may ensue and due to thedisruption of proteins and collagen there is an increased risk forwrinkle formation. The increased brain temperature correlates to theamount of thermal radiation absorbed by the body, and the duration ofexposure of the temperature level times the level of temperature is anindicator of the risk of thermal damage, wrinkle formation, and skincancer.

The present invention provides an alarm system that can be set up toalert in real time when it is time to avoid sun exposure in order toprevent further absorption of thermal radiation and reduce the risk ofdermatologic changes, as can occur during outdoor activities or at thebeach. In addition, thermal damage to the skin prevents the skin fromadequately cooling itself and can result in increasing the risk ofdehydration which further increases the temperature. The presentinvention helps preserve the beauty and health of people exposed to sunlight and during outdoor activities while allowing full enjoyment of thesun and the benefits of sun light.

By the present invention, a method for timing sun exposure includes thesteps of measuring body temperature, reporting the value measured andavoiding sun exposure for a certain period of time based on the levelmeasured.

Hypothermia is the number one killer in outdoor activities in the U.S.and Europe. Hypothermia also decreases athletic performance and leads toinjuries. It is very difficult to detect hypothermia because thesymptoms are completely vague such as loss of orientation and clumsinesswhich are indistinguishable from general behavior. Without measuringcore temperature and having an alert system when the temperature fallsoutside safe levels it is impossible to prevent hypothermia due to thevague symptoms. The present invention can alert an individual abouthypothermia during skiing, scuba diving, mountain climbing and hiking.The present invention provides means to precisely inform when certaintemperature thresholds are met, either too high or too low temperature.

The present invention continuously monitors the brain temperature and assoon as a temperature spike or fever occurs it activates diagnosticssystems to detect the presence of infectious agents, which can be donelocally in the BTT site, or the infectious agents can be identified inother parts of the body such as the blood stream or the eyelid pocket.The present invention can be also coupled to drug dispensing devices forthe automated delivery of medications in accordance with the signalproduced at the BTT site including transcutaneous devices, iontophoresisor by injection using a pump.

The invention also includes a tool for family planning. The system candetect spike and changes in basal temperature and identify moment ofovulation and phases of the menstrual cycle. This allows a woman to planpregnancy or avoid pregnancy. This eliminates the need for invasivedevices used for monitoring time for artificial insemination not onlyfor humans but also animals. The invention can yet detect the start ofuterine contractions (parturition) and allow a safer birth for animals.Support structures can be equally used in the BTT of animals.

The present invention also includes Automated Climate control accordingto the value measured at the BTT. The temperature of the user controlsthe temperature in a car. When the body starts to warm up, the signalfrom the apparatus of the invention automatically activates the airconditioner according to the user settings, alternatively it activatesheat when the body is cold. This automation allows drivers toconcentrate on the road and thus can reduce the risk for car crashes. Itis understood that other articles that can affect body temperature canbe controlled by the present invention including vehicle seats.

Current vehicle climate control systems are dramatically overpoweredbecause they are designed to heat/cool the vehicle cabin air mass froman extreme initial temperature to a standard temperature within acertain period of time. Because people have different thermal needs forcomfort, there is a consistent manual change of the temperature settingsand said manual further increase consumption of energy. For instance,car temperature is set to remain at 73 F. Some people after 15 minutesmay feel that it is too cold and some people may feel it is too hot.Subsequently the passenger changes the setting to 77 and then feels hotafter another 10 minutes, and needs to manually change the set pointsagain, and the process goes on. In addition the needs differ for peopleof different age, people with diabetes and other diseases, and male andfemale.

Manual frequent adjusting of a vehicle's climate control may increasefuel consumption 20% and increase emissions of pollutants such as carbonmonoxide and nitrogen oxides.

The present invention provides an automated climate control in which thebrain temperature controls the air conditioner and vehicle seats whichmaximizes comfort and minimizes fuel consumption. The improved fueleconomy provided by the present invention protects the environment dueto less pollutants affecting the ozone layer; improves public health bydecreasing emission of toxic fumes, and increases driver's comfort andsafety by less distractions with manually controlling a car's climatecontrol.

Thermal environment inside transportation vehicles can be adjustedaccording to the temperature at the BTT site including contact sensormeasurement and non-contact sensor measurement such as an infraredsensor or thermal image. The temperature at the BTT adjusts any articleor device in the car that changes the temperature inside the cabinincluding air conditioner and heater, vehicle seats, doors, windows,steering wheels, carpets on the floor of the vehicle, and the like.Exemplarily, the temperature at the BTT site adjusts the amount ofthermal radiation going through a window of a vehicle, if the BTT sendsa signal indicating hot sensation then the windows for instance willdarken to prevent further heat from entering the car, and vice versa ifcold is perceived the window changing its light transmissibility toallow more heat waves to penetrate the vehicle's cabin. Any articletouching the body or in the vicinity of the body can be adapted tochange its temperature to achieve thermal comfort for the occupants ofthe vehicle.

Besides the support structures and thermal imaging systems described inthe present invention to monitor and adjust temperature of a cabin of atransportation vehicle, it is understood that a contact lens inside theeyelid pocket with a temperature sensor can also be adapted to adjustthe temperature inside the cabin of the vehicle. Exemplarytransportation vehicles include cars, trucks, trains, airplanes, ships,boats, and the like.

It is also understood that the sensing system can include sensors inother parts of the body working in conjunction with the temperaturesensor measuring temperature and/or thermal radiation at the BTT site.Thermal energy transfer from an article to an occupant of a vehicle canoccur by any of radiation, convection, and the like, and any mechanismto transfer deliver, or remove thermal energy can be adjusted based on atemperature signal measured at the BTT.

The present invention provides a more energy-efficient system to achievethermal comfort of the passengers in any type of transportation vehiclein existence or being developed with any type of sensor alone at the BTTsite or in conjunction with sensors in other parts of the body.

Likewise, automated climate control at home, work, or any confined areacan be achieved by activating the thermostat directly or via BlueToothtechnology based on the temperature measured at the BTT in accordancewith the present invention. Besides convenience and comfort, thisautomation allows saving energy since gross changes manually done in thethermostat leads to great energy expenditure.

It is understood that any body temperature measuring system can provideautomated climate control or adjust temperature of articles inaccordance with the principles of the present invention.

The present invention yet includes methods for reducing weight. Itincludes monitoring of temperature during programs for weight reductionbased on increasing body heat to reduce said weight. The system alertsathletes on a weight losing program to prevent injury or death byoverheating. The system can monitor temperature of people in sauna,steam rooms, spas and the like as part of weight reduction programs inorder to prevent injuries and enhance results.

Yet, methods to enhance memory and performance besides preserving healthis achieved by providing an automated mechanism to control ambienttemperature and surrounding body temperature based on the braintemperature measured by the present invention. Human beings spend aboutone third of their lives sleeping. Many changes in body temperatureoccur during sleep. All of the metabolism and enzymatic reactions in thebody are dependent on adequate level of temperature. The adequatecontrol of ambient temperature which matches the needs of bodytemperature such as during sleeping have a key effect on metabolism.Adequate ambient temperature and surrounding temperature of objectswhich matches body temperature allow not only for people to sleepbetter, but also to achieve improved efficiency of enzymatic reactionswhich leads to improved mental ability and improved immune response. Avariety of devices such as blankets, clothing, hats, mattress, pillows,or any article touching the body or in the vicinity of the body can beadapted to automatically increase or decrease temperature of saidarticles according to the temperature signal from the present invention.

The body naturally becomes cooler during the night and many people haverestless sleep and turn continuously in bed because of that temperatureeffect. Since the tossing and turning occurs as involuntary movementsand the person is not awake, said person cannot change the stimuli suchas for instance increasing room temperature or increasing temperature ofan electric blanket. The present invention automatically changes theambient temperature or temperature of articles to match the temperatureneeds of the person. This is particularly useful for infants, elderly,diabetics, neuro-disorders, heart disease, and a variety of otherconditions, since this population has reduced neurogenic response tochanges in body temperature, and said population could suffer moreduring the night, have increased risk of complications besides decreasedproductivity due to sleep deprivation. Accordingly, the temperature ofan electrical blanket or the ambient temperature is adjustedautomatically in accordance with the temperature at the BTT. When lowtemperature at the BTT is detected by the apparatus of the invention awireless or wired signal is transmitted to the article to increase itstemperature, and in the case of an electrical blanket or heating system,the thermostat is automatically adjusted to deliver more heat.

The invention also provides devices and methods to be used with biofeedback activities. A brain temperature signal from the sensor at theBTT site produces a feedback signal as an audio tone or visual displayindicating temperature and a series of tones or colors identify if thebrain temperature is increasing (faster frequency and red) or decreasing(lower frequency and blue). The display devices can be connected bywires to the support structure holding the sensor at the BTT site.

Head cooling does not change brain temperature. Athletes, military,firefighters, construction workers and others are at risk of heatstrokedespite pouring cold water on their head or using a fan. Medicallyspeaking that is a dangerous situation because the cool feeling sensedin the head is interpreted as internal cooling and the physical activityis maintained, when in reality the brain remains at risk of thermalinduced damage and heatstroke. Other medical challenges related totemperature disturbances concern response time. The brain has a slowerrecovery response to temperature changes than core temperature (internaltemperature measured in rectum, bladder, esophagus, and other internalmechanisms). Thus, internal measurement may indicate stable temperaturewhile the brain temperature remains outside safe levels, with risk ofinduced damage to cerebral tissue, either due to hypothermia orhyperthermia. The only medically acceptable way to prevent cerebraltissue damage due to temperature disturbances is by continuousmonitoring brain temperature as provided by the present invention.

The present invention utilizes a plurality of active or passive sensorsincorporated in support structures for accessing a physiologic tunnelfor measuring biological parameters. The present invention preferablyincludes all functions in a miniature semiconductor chip, which as anintegrated circuit, incorporates sensor, processing and transmittingunits and control circuits.

Additional embodiments include temperature measurement and massscreening for fever and temperature disturbances (hyperthermia andhypothermia) comprising a body radiation detector, herein referred as aBTT ThermoScan, which comprises a thermal imaging system acquiring athermal image of the end of the BTT. The BTT ThermoScan of the presentinvention has sufficient temperature and isotherm discrimination formonitoring temperature at all times and without the possibility of themeasurement to be manipulated by artificial influences.

The BTT ThermoScan detects the brain temperature and provides an imagecorresponding to the BTT area or an image that includes the BTT area.

The BTT ThermoScan comprises a camera that converts thermal radiationinto a video image that can be displayed on a screen, such as the imagesseen in FIGS. 1A, 1B, 3A, 4A, 5A, 5C, 7A, 7B, 8A, 8B, 9A and 9B (foranimals), and most preferably the image seen in FIG. 1B. The radiantenergy emitted from the body and the BTT area is detected and imagedwithin the visible range.

Human skin at the BTT site has a high emissivity (e in theStefan-Boltzman formula) in the infrared range, nearly equal to a blackbody. A video image of people walking by and looking at the BTTThermoScan lens is captured and a customized software is adapted todisplay a colored plot of isotherm lines, as the software used toacquire the image of FIG. 1B in which any point at 99 degrees Fahrenheitis seen as yellow. For detection of SARS the software is adapted todisplay in yellow any point in the BTT area above 100 degreesFahrenheit. When the yellow color appears on the screen, the software isadapted to provide an automatic alarm system. Therefore when the BrainTemperature Tunnel area appears as yellow on the screen the alarm isactivated. It is understood that any color scheme can be used. Forinstance, the threshold temperature can be displayed as red color.

As shown in FIGS. 7A and 7B, cold challenge experiments were performedand demonstrated the stability of thermal emission in the BTT area. Thecold challenge consisted of continuous capturing thermal infrared imageswhile a subject is exposed to cold including facing a cold air generator(eg., air conditioner and fans), drinking cold liquids, body immersionin cold water, and spraying alcohol on the skin. Despite artificialmeans used to artificially change the body temperature the radiationfrom the BTT area remained intact, and can be seen as the bright whitespots in the BTT area. Contrary to that, the face gradually becamedarker indicating cooling of the face during the exposure to cold. FIG.7B shows a darker face compared to the face in FIG. 7A, but without anychange in the thermal radiation from the BTT area.

In addition to cold challenges, hot challenges was performed in order toartificially increase body temperature and included exercise, peoplewith sunburn, facing a heater, alcohol ingestion, cigarette smoking andbody immersion in hot water. In all of those experiments the BTT arearemained stable, but the remaining of the face had a change oftemperature reflecting skin temperature, not internal brain temperature.As seen in FIGS. 2A to 2C the brain is completely insulated from theenvironment, with the exception of the end of the BTT. The currenttechnology will have too many false positives and someone could bestopped at an airport or at customs just for drinking some alcohol orsmoking a cigarette, making the devices in the prior art ineffective.Therefore, the present invention provides a system and method thateliminates or reduces both false negatives and false positives whenusing thermal imaging detection systems.

Many useful applications can be achieved including mass screening forfever, screening for hyperthermia in athletes at the end of a sportsevent (e.g., marathon), screening for hypothermia or hyperthermia formilitary personnel so as to select the one best fit physiologically forbattle, and any other temperature disturbance in any condition in whicha BTT ThermoScan can be installed.

One particular application consists of prevention of a terrorist attackby a terrorist getting infected with a disease (e.g., SARS—Severe AcuteRespiratory Syndrome) and deceiving thermometers to avert detection offever when entering the country target for the terrorist attack.

SARS could potentially become a high terrorist threat because it cannotbe destroyed. By being naturally created, SARS could become a weapon ofmass destruction that cannot be eliminated despite use of military forceor diplomatic means. A terrorist can get the infection with the purposeof spreading the infection in the target country. With currenttechnology any device can be deceived and current devices would measurenormal temperature when indeed fever is present. Simple means can beused by a terrorist, such as washing their face with cold water or iceor by immersion in cold water, to manipulate any device in the prior artused for measuring fever including current infrared imaging systems andthermometers. The thermal physiology of the body, as it is measured andevaluated by the prior art, can be manipulated and the measurementperformed can give a false negative for fever.

A terrorist with SARS could easily spread the disease by many waysincluding individually by shaking hands with clerks on a daily basis ona mass scale by spending time in confined environments such as movietheater, a concert, grocery store, a government building, and others, orby contaminating water or drinking fountains. All of those peopleinfected do not know they caught the disease and start to spread SARS tofamily members, co-workers, friends and others, who subsequently willinfect others, leading to an epidemic situation.

From a medical standpoint, intentional spread of SARS can haveimmeasurable devastating effects. People not knowing they have thedisease may go to a hospital for routine checks or people not feelinggood may go to a hospital for routine checks. Patients and others comingto the hospital can then acquire the disease. Admitted patients, who aredebilitated, can easily acquire SARS. Spread of SARS in a hospitalenvironment can be devastating and the hospital may need to shut down.Therefore, one person with SARS can lead to the shut down of a wholehospital. Considering that people infected with the disease may go todifferent hospitals, several hospitals could get contaminated and wouldhave to be partially or completely shut down. This could choke thehealth care system of a whole area, and patients would have to betransported to other hospitals. Those patients may have acquired SARS aswell as perpetuating the transmission cycle. If this is done in severalareas by a concerted terrorist effort, much of the health care system ofa country could be choked, besides countless doctors and nurses couldbecome infected with SARS which would further cripple the health caresystem by shortage of personnel.

The key to prevent the catastrophic effects of a terrorist attack ispreparedness. The apparatus and methods of the present invention candetect SARS and cannot be manipulated by artificial means. Placement ofthe BTT ThermoScan of the present invention at the borders, ports andairports of a country can prevent the artificial manipulation of thetemperature measurement and a possible terrorist attack. The system ofthe present invention can identify at all times and under anycircumstances the presence of SARS and other diseases associated withfever.

In addition, mass screening of athletes could be performed with a BTTThermoScan installed at the finish line. An alert is activated for anyathlete who crosses the finish line with a high level of hyperthermia.Therefore immediate care can be delivered allowing for the best clinicaloutcome since any delay in identifying hyperthermia could lead toheatstroke and even death. The BTT ThermoScan is adapted to view atleast a portion of the BTT area. BTT ThermoScan detects the braintemperature and provides an image corresponding to or that includes theBTT area. Despite athletes pouring water on their head, the BTTThermoScan precisely detects the thermal status of the body by detectingthe temperature at the BTT.

Temperature disturbances such as hyperthermia and hypothermia can impairmental and physical function of any worker. Drivers and pilots inparticular can have reduced performance and risk of accidents whenaffected by temperature disturbances. The BTT ThermoScan can be mountedin the visor of a vehicle or plane to monitor body temperature with thecamera of the BTT ThermoScan capturing a thermal image of the BTT of thedriver or pilot and providing an alert whenever a disturbance isnoticed. It is understood that any thermal imaging system can be mountedin a vehicle or airplane to monitor body temperature and alert driversand pilots.

The BTT ThermoScan also includes monitoring mass screening of childrenand people at risk during flu season. With the shortage of nurses anautomated screening can greatly enhance the delivery of health care tothe ones in need. When a student walking by the infrared camera isidentified as having a temperature disturbance (e.g., fever) aconventional digital camera is activated and takes a picture of thestudent. The picture can be emailed to the school nurse that canidentify the student in need of care or automatically by using storeddigital pictures.

Hospitals, factories, homes, or any location that can benefit fromautomated mass or individual screening of temperature disturbances canuse the thermal imaging apparatus in accordance with the presentinvention.

It is understood that an apparatus comprised of a radiation sourceemitting a wavelength around 556 nm at the BTT site can be used fordetermining the concentration of hemoglobin. The hemoglobin present inthe red blood cells at the terminal end of the BTT strongly absorbs the556 nm wavelength and the reflected radiation acquired by aphotodetector determines the amount of hemoglobin. Blood flow can beevaluated by knowing the amount with thermal radiation, the higheramount of the thermal radiation indicating higher blood flow inaccordance to a mathematical model.

Positioning of contact sensors, non-contact sensors, and thermal imagingcamera are facilitated by external visible anatomic aspects that may bepresent. The cerebral venous blood can be seen under the skin in themedial canthal area next to the corner of the eye. Therefore a methodfor measuring temperature includes the step of visually detecting theblue or bluish color of the skin at the BTT area and positioning thesensor on or adjacent to the blue or bluish area. For subjects of darkerskin, a distinctive feature of difference skin texture in the BTT areanext to the medial corner of the eye can be used as the reference formeasurement.

The present invention includes devices for collecting thermal radiationfrom a BTT site, devices for positioning temperature sensitive devicesto receive thermal radiation from the BTT site and devices forconverting said thermal radiation into the brain temperature. Thepresent invention also provides methods for determining braintemperature with said methods including the steps of collecting thethermal emission from the BTT site, producing a signal corresponding tothe thermal emission collected, processing the signal and reporting thetemperature level. The invention also includes devices and methods forproper positioning of the temperature sensor in a stable position at theBTT site.

It is also an object of the present invention to provide supportstructures adapted to position a sensor on the end of a tunnel on theskin to measure biological parameters.

It is an object of the present invention to provide apparatus andmethods to measure brain temperature including patches, adhesivesstrips, elastic devices, clips and the like containing sensorspositioned on a physiologic tunnel.

It is an object of the present invention to provide apparatus andmethods to measure brain temperature including thermal imaging systemscontaining infrared sensors sensing infrared radiation from the BTT.

It is an object of the present invention to provide multipurposeeyeglasses equipped with medial canthal pads containing sensorspositioned on a physiologic tunnel for measuring biological parameters

It is another object of the present invention to provide new methods andapparatus for measuring at least one of brain temperature, chemicalfunction and physical function.

It is yet an object of the invention to provide apparatus that fit onboth adults and children.

It is also an object of the invention to provide apparatus that reportthe signal produced at the tunnel by at least one of wired connection toreporting devices, wireless transmission to reporting devices and localreporting by audio, visual or tactile devices such as by vibrationincorporated in support structures.

It is yet another object of the present invention to provide apparatusthat allow the wearer to avoid dehydration or overhydration (waterintoxication).

It is a further object of the present invention to provide methods andapparatus that allows athletes and sports participants to increase theirperformance and safety.

It is yet an object of the present invention to provide supportstructure positioned sensors on a tunnel which can be worn at least byone of athletes during practice and competition, military duringtraining and combat, workers during labor and the general public duringregular activities.

It is another object of the present invention to increase safety andcomfort in vehicles by providing automated climate control and vehicleseat control based on the core temperature of the occupants of thevehicle.

It is an object of the present invention to provide methods andapparatus that act on a second device based on the level of thebiological parameter measured.

It is another object of the invention to provide methods and apparatusto preserve skin health, reduce risk of wrinkles and reduce the risk ofskin cancer by preventing sun damage by thermal radiation and alertingthe wearer when the temperature has reached certain thresholds.

It is also an object of the invention to provide methods and apparatusfor achieving controlled weight loss based on heat-based weight lossapproach.

It is also an object of the invention to provide methods and apparatusto alert athletes in a weight losing program based on increasing bodytemperature to prevent injury or death by overheating.

It is also an object of the invention to provide methods and apparatusthat allow monitoring fever and spikes of temperature.

It is also an object of the invention to provide a device for familyplanning by detecting time of ovulation.

It is a further object of the invention to provide methods and apparatusfor the delivery of medications in accordance with the signal producedat the tunnel.

It is yet an object of the invention to provide methods and apparatusthat enhance occupational safety by continually monitoring biologicalparameters.

It is also an object of the invention to provide an article ofmanufacture with a sensing apparatus positioned on a tunnel formonitoring biological parameters that can be fitted or mounted in atleast one of the frame of eyeglasses, the nose pads of eyeglasses, thestructure of a head mounted gear and clothing.

The invention also features transmitting the signal from the supportstructure to act on at least one of exercise equipment, bikes, sportsgear, protective clothing, footwear and medical devices.

It is yet an object of the invention to provide support structures thattransmit the signal produced at the tunnel to treadmills and otherexercise machines for keeping proper hydration and preventingtemperature disturbances of the user.

It is yet another object of the invention to provide apparatus andmethods for monitoring biological parameters by accessing a physiologictunnel using active or passive devices.

The invention yet features transmission of the signal from the supportstructures to watches, pagers, cell phones, computers, and the like.

These and other objects of the invention, as well as many of theintended advantages thereof, will become more readily apparent whenreference is made to the following description taken in conjunction withthe accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a thermal infrared image of the human face showing the braintemperature tunnel.

FIG. 1B is a computer generated thermal infrared color image of thehuman face showing the brain temperature tunnel.

FIG. 2A is a schematic diagram showing a physiologic tunnel.

FIG. 2B is a cross-sectional schematic diagram of the human head showingthe tunnel.

FIG. 2C is a coronal section schematic diagram showing the cavernoussinus of FIG. 2B.

FIG. 3A is a thermal infrared image of the human face showing thetunnel.

FIG. 3B is a schematic diagram of the image in FIG. 3A showing thegeometry at the end of the tunnel.

FIG. 4A is a thermal infrared image of the side of the human faceshowing a general view of the main entry point of the brain temperaturetunnel.

FIG. 4B is a schematic diagram of the image in FIG. 4A.

FIG. 5A is a thermal infrared image of the front of the human faceshowing the main entry point of the brain temperature tunnel.

FIG. 5B is a schematic diagram of the image in FIG. 5A.

FIG. 5C is a thermal infrared image of the side of the human face inFIG. 5A showing the main entry point of the brain temperature tunnel.

FIG. 5D is a schematic view of the image in FIG. 5C.

FIG. 6 is a schematic view of the face showing the general area of themain entry point of the tunnel and peripheral parts.

FIG. 6A is a schematic diagram showing the brain temperature tunnel andthe metabolic tunnel.

FIGS. 7A and 7B are thermal infrared images of the human face before andafter cold challenge.

FIGS. 8A and 8B are thermal infrared images of the human face ofdifferent subjects showing the tunnel.

FIGS. 9A and 9B are thermal infrared images of animals showing a tunnel.

FIG. 10 is a perspective view of a preferred embodiment showing a personwearing a support structure comprised of a patch with a passive sensorpositioned on the skin at the end of the tunnel in accordance with thepresent invention.

FIG. 11 is a perspective view of another preferred embodiment showing aperson wearing a support structure comprised of a patch with a passivesensor positioned on the skin at the end of the tunnel in accordancewith the present invention.

FIG. 12A is a front perspective view of a person wearing a supportstructure comprised of a patch with an active sensor positioned on theskin at the end of the tunnel in accordance with the present invention.

FIG. 12B is a side schematic view showing the flexible nature of thesupport structure shown in FIG. 12A.

FIG. 13 is a schematic block diagram of one preferred embodiment.

FIG. 14 is a schematic diagram of one preferred embodiment of theinvention interacting with devices and articles of manufacture.

FIGS. 15A to 15E are schematic views showing preferred embodiments ofthe invention using indicators.

FIGS. 16A to 16C are perspective views of a preferred embodiment showinga person wearing support structures incorporated as patches.

FIG. 17 is a perspective view of another preferred embodiment showing aperson wearing a support structure incorporated as a clip with a sensorpositioned on the skin at the end of the tunnel in accordance with thepresent invention.

FIG. 18 is a perspective view of another preferred embodiment showing aperson wearing a support structure with a sensor positioned on the skinat the end of the tunnel and connected by a wire.

FIGS. 19A1, 19A2, 19B, 19C and 19D are schematic diagrams of preferredgeometry and dimensions of support structures and sensing devices.

FIGS. 20A to 20C are schematic diagrams of preferred dimensions of theouter edge of support structures in relation to the outer edge ofsensing devices.

FIGS. 21A and 21B are schematic diagrams of preferred positions ofsensing devices.

FIGS. 22A to 22C are perspective views of preferred embodiments showinga person wearing a support structure incorporated as a medial canthalpad with a sensor positioned on the skin at the end of the tunnel inaccordance with the present invention.

FIGS. 23A and 23B are perspective views of an alternative embodimentshowing a support structure comprised of modified nose pads with asensor positioned on the skin at the end of the tunnel in accordancewith the present invention.

FIG. 24 is a perspective view of another preferred embodiment of supportstructure in accordance with the invention.

FIG. 25 is a perspective view of one preferred embodiment of supportstructure showing additional structures for including a sensor.

FIG. 26A is a rear perspective view of one preferred embodiment of asupport structure with a display device.

FIG. 26B is a front perspective view of one preferred embodiment of asupport structure with a display device.

FIG. 27 is an exploded perspective view of another preferred embodimentshowing a three piece support structure.

FIG. 28A is an exploded perspective view of one preferred embodiment ofsupport structure showing a removable medial canthal piece.

FIG. 28B is a rear perspective view of the removable medial canthalpiece of FIG. 28A.

FIG. 28C is a front perspective view of the removable medial canthalpiece of FIG. 28B.

FIG. 29 is a rear perspective view of one preferred embodiment of asupport structure incorporated as a clip-on for eyeglasses.

FIG. 30 is a perspective view of one alternative embodiment of a supportstructure with medial canthal pads that uses an adhesive backing forsecuring to another structure.

FIG. 31A is a top perspective view of one alternative embodiment of asupport structure with holes for securing medial canthal pads.

FIG. 31B is a magnified perspective view of part of the supportstructure of FIG. 31A.

FIG. 31C is a side perspective view of part of the support structure ofFIG. 31B.

FIG. 31D is a side perspective view of a medial canthal piece secured atthe support structure.

FIG. 32A is a perspective view of a person wearing a support structurecomprised of medial canthal caps secured on top of a regular nose pad ofeyeglasses.

FIG. 32B is a perspective view of the medial canthal cap of FIG. 32A.

FIG. 33A is an exploded perspective view of a medial canthal cap beingsecured to the nose pad.

FIG. 33B is a perspective view of the end result of the medial canthalcap secured to the nose pad.

FIG. 34 is a perspective view of a modified rotatable nose pad toposition a sensor on the skin at the end of the tunnel in accordancewith the present invention.

FIG. 35 is a schematic view of another preferred embodiment of thepresent invention using spectral reflectance.

FIG. 36 is a schematic view of a person showing another preferredembodiment in accordance with the present invention using spectraltransmission.

FIG. 37 is a schematic cross-sectional view of another preferredembodiment of the present invention using thermal emission.

FIG. 38 is a side perspective view of an alternative embodiment usinghead mounted gear as a support structure.

FIG. 39 is a schematic diagram of a preferred embodiment for generatingthermoelectric energy to power the sensing system.

FIG. 40 is a perspective view of a preferred embodiment for animal use.

FIGS. 41A and 41B are perspective views of an alternative embodiment ofa portable support structure with a sensor positioned at the tunnel.

FIGS. 42A and 42B are schematic diagrams showing a non-contact sensor inaccordance with the present invention.

FIG. 43A to 43C are diagrams showing preferred embodiments for thediameter of the cone extension

FIGS. 44A and 44B shows alternative geometries and shapes of an end ofthe extension.

FIGS. 45A and 45B shows exemplary geometries and shapes for a supportstructure containing a contact sensor.

FIGS. 46A to 46D shows exemplary geometries and shapes for medialcanthal pads or modified nose pads.

FIG. 47 is a schematic block diagram showing a preferred embodiment ofthe infrared imaging system of the present invention.

FIGS. 48 to 51 are schematic views showing the infrared imaging systemof the present invention mounted in a support structure in differentlocations for screening people for temperature changes.

FIG. 52A is a schematic view showing the infrared imaging system of thepresent invention mounted in a vehicle.

FIG. 52B is a representation of an illustrative image generated with theinfrared imaging system of FIG. 52A.

FIG. 53 shows a flowchart illustrating a method used in the presentinvention.

FIGS. 54A and 54B are perspective views of a preferred embodimentcoupled to a head gear.

FIG. 55 is a perspective view of a preferred embodiment comprised of amask and an air pack.

FIGS. 56A and 56B are schematic diagrams showing a BTT entry pointdetection system in accordance with the present invention.

FIG. 57 is a schematic diagram showing an automated BTT entry pointdetection system.

FIGS. 58A to 58C are schematic views showing alternative supportstructures in accordance with the present invention.

FIG. 59 is a schematic diagram showing bidirectional flow of thermalenergy in the BTT.

FIGS. 60A to 60C show diagrammatic views of a preferred BTT thermalpack.

FIG. 61 is a schematic frontal view showing a preferred BTT thermal packin accordance with the present invention.

FIG. 62 is a schematic cross sectional view of a BTT thermal pack.

FIG. 63A is a schematic cross sectional view of a BTT thermal pack inits relaxed state.

FIG. 63B is a schematic cross sectional view of a BTT thermal pack ofFIG. 63A in its compressed state conforming to the BTT area.

FIG. 64A is a side cross-sectional schematic view of a head of a personwith a BTT thermal pack.

FIG. 64B is a frontal schematic view of the eye area with BTT thermalpack of FIG. 64A.

FIG. 65 shows a perspective view of a BTT thermal pack containing a rod866.

FIG. 66 shows a schematic view of another embodiment of dual bag BTTthermal pack.

FIG. 67A shows a frontal schematic view of a BTT thermal mask.

FIG. 67B shows a side cross-sectional schematic view of the BTT thermalmask of FIG. 67A.

FIG. 67C shows a perspective frontal view of the BTT thermal mask ofFIG. 67A on the face and on the BTT.

FIG. 68A shows a perspective frontal view of a BTT thermal packsupported by support structure comprised of eyewear.

FIG. 68B shows a perspective frontal view of a BTT thermal packsupported by support structure comprised of a clip.

FIGS. 69A to 69C show perspective views of a preferred BTT thermal pack.

FIG. 69D is a perspective view of a BTT thermal pack of FIG. 69Apositioned on the BTT.

FIG. 70 is a schematic diagram showing a hand held non-contact BTTmeasuring device.

FIGS. 71A to 71C are schematic diagrams showing hand held infrared BTTmeasuring devices.

FIG. 72 is a schematic diagram showing a hand held contact sensormeasuring device.

FIG. 73 is a schematic diagram showing heat transfer devices coupled toBTT measuring devices.

FIG. 74 is a perspective diagram showing preferred BTT measuring devicesfor animals.

FIGS. 75A to 75E are graphs showing thermal signatures.

FIGS. 76A and 76B are schematic diagrams showing an antenna arrangement.

FIGS. 77A to 77C are schematic diagrams showing a support structurecomprised of hook and loop fastener.

FIG. 78 is a schematic diagram showing a support structure comprised ofhook and loop fastener with attached lenses.

FIGS. 79A and 79B are perspective images of alternative supportstructures.

FIG. 80 is a schematic diagram showing a support structure of FIG. 79A.

FIGS. 81A and 81D are schematic diagrams of a preferred supportstructure.

FIGS. 81C and 81D are perspective diagrams showing a support structureof FIG. 81A.

FIG. 82 is a schematic diagram showing electrical arrangement of asupport structure comprised of eyewear.

FIG. 83 is a perspective view showing an automated climate controlsystem.

FIG. 84 is a perspective frontal view showing an nasal airway dilator asan extension of a patch of the present invention.

FIGS. 85A to 85C are schematic diagrams showing kits in accordance withthe present invention.

FIG. 86A is a perspective view of a support structure for the braintemperature tunnel sensor assembly of the present invention.

FIG. 86B illustrates an alternate embodiment with a pivotable supportarm of the support structure.

FIG. 86C is a detailed view of a sensor at one end of the supportstructure.

FIG. 86D is a planar diagrammatic view of an alternate embodiment of thesupport structure and sensor assembly.

FIG. 86E is a diagrammatic side view of the embodiment of FIG. 86D.

FIG. 86F illustrates an irregular geometric shape of a body portionsupported by a triangular shaped arm.

FIG. 86G is a diagrammatic perspective view of an alternate embodimentof a support structure and sensor assembly.

FIG. 86H is a sectional view of the embodiment shown in FIG. 86G.

FIG. 86I is a bottom planar view of the sensor assembly illustrating thehousing light emitter and light detector.

FIG. 86J is a diagrammatic planar view of an alternate embodiment of thesupport structure and sensor assembly.

FIG. 86K illustrates an embodiment worn by a user including an adhesivepatch and a light emitter-light detector pair located adjacent to theedge of the adhesive patch.

FIG. 86L illustrates an alternate embodiment of the adhesive patch.

FIG. 86M illustrates a cloverleaf shaped adhesive patch embodiment.

FIG. 86M(1) illustrates a rear view of an adhesive patch.

FIG. 86N illustrates the details of a light emitter-detector pair.

FIG. 86P illustrates an alternate embodiment of a sensor assembly.

FIG. 86P(1) diagrammatically illustrates the noncontact measurement ofthe brain tunnel.

FIG. 86P(2) schematically illustrates a light source directing radiationat the brain tunnel and measurement of reflected radiation.

FIG. 86P(3) diagrammatically illustrates a handheld sensing device fornoncontact measurement at the brain tunnel.

FIG. 86P(4) illustrates a noncontact measurement at the brain tunnel.

FIG. 86P(5) illustrates a sensing device and a sensor mounted on aweb-camera for measurement of radiation from the brain tunnel.

FIG. 86Q is a sectional view of a sensing device shown in detail.

FIG. 86Q(1) is a perspective diagrammatic view of a measuring portion ofa sensor assembly.

FIG. 86R illustrates a perspective view of a sensing device mounted on asupport structure.

FIG. 86R(1) illustrates a sensing device worn by a user.

FIG. 86R(2) illustrates a sensing device having a swivel mechanism atthe junction of an arm and a body.

FIG. 86R(3) illustrates the swivel assembly of a sensing device andsupport structure worn by a user.

FIG. 86S(1) is a side view of a sensing device having a straightextending wire.

FIG. 86S(2) shows a sensing device worn by a user with an arm bent intoposition.

FIG. 86T(1) illustrates a sensing device including an arm, measuringportion and plate.

FIG. 86T(2) shows a sensing device and support structure formed ofseparable pieces.

FIG. 86T(3) shows an alternate embodiment of a sensing device andsupport structure with different separable pieces from FIG. 86T(2).

FIG. 86U illustrates the specialized skin area of the brain tunnel witha patch worn over the brain tunnel area.

FIG. 87 schematically illustrates a comparison betweentrans-subcutaneous measurements of the arterial oxygen pressure aspreviously known and as measured by the present invention.

FIG. 87A illustrates the advantageous use of a small heating element.

FIG. 87B illustrates a convex sensing surface for a sensing system.

FIG. 87C illustrates a specialized two-plane surface including a convexsurface and a flat central surface.

FIG. 88 schematically illustrates the placement of a sensor assembly andits support structure on the face of a wearer.

FIG. 89 is a diagrammatic perspective view of a sensor assemblymeasuring portion mounted on a support structure.

FIG. 90A illustrates a routing of a transmission wire through thesupport structure.

FIG. 90B is a perspective view illustrating the path of the wire throughthe support structure.

FIG. 90C is a side view illustrating the path of the transmission wire.

FIG. 90D is a top view illustrating the path of the transmission wire.

FIG. 90E illustrates a path of the transmission wire from a bottom view.

FIG. 90F illustrates the path of the wire from an end view.

FIG. 90G illustrates a sensing device including its support body andsensor head.

FIG. 90H illustrates the locating of the sensing assembly on the face ofa wearer.

FIG. 90I illustrates a sensing device worn by a user and held in placeby a headband.

FIG. 90J illustrates a two part separable sensing device worn by a userand held in place by a headband.

FIG. 91 illustrates a nose bridge and clip for mounting a sensingdevice.

FIG. 92A illustrates a specialized support and sensing structure.

FIG. 92B illustrates a specialized support and sensing structure worn bya user.

FIG. 92C illustrates the mounting of a specialized sensing device oneyeglasses.

FIG. 92D illustrates the support and sensing structure mounted on aframe of eyeglasses.

FIG. 92E illustrates a bottom view of an LED based sensing eyeglass.

FIG. 92F illustrates a wireless based sensing pair of eyeglasses.

FIG. 93A illustrates a patch sensing system.

FIG. 94A illustrates a system for mounting a sensing device on ananimal.

FIG. 94B illustrates a multilayer protection cover mounted on a sensingsystem for an animal.

FIG. 95A illustrates a mounting of an alert device on a shoe of a user.

FIG. 95B-1 illustrates the transmission of signals to devices worn by auser.

FIG. 95B-2 is an enlarged view of an alert device worn by a user.

FIG. 95C-1 schematically illustrates an algorithm for heart monitoring.

FIG. 95C-2 schematically illustrates an algorithm for body temperaturemonitoring.

FIG. 95D schematically illustrates a brain temperature tunneltransmitting system, a heart rate transmitting system and a shoereceiving system.

FIG. 96 illustrates an apparatus for measuring biological parameters.

FIG. 96A illustrates a known contact sensing tip of a rod.

FIG. 96B illustrates a specialized temperature measuring device of thepresent invention.

FIG. 96C is a schematic perspective view of the tip of the rod.

FIG. 96D illustrates an alternate embodiment of a rod having a sensor.

FIG. 96E is a known thermometer.

FIG. 96F illustrates a sensor housed in an end of a stylus.

FIG. 96-G1 illustrates a glucose sensing device.

FIG. 96-G2 illustrates a specialized cap of a sensing device.

FIG. 96H illustrates a specialized end of a thermometer.

FIG. 96J illustrates a stylus having a touching end and a sensing end.

FIG. 96K illustrates a stylus connected by a wireless system with anelectronic device.

FIG. 96L illustrates a sensing-writing instrument.

FIG. 96M illustrates a telephone having a sensing antenna.

FIG. 96N illustrates a sensing antenna.

FIG. 96P illustrates a sensing antenna.

FIG. 96Q-1 is a planar view of a rod-like sensing device.

FIG. 96Q-2 is a side view of the rod-like structure.

FIG. 96Q-3 illustrates a pair of light emitter-light detector sensors atthe end of the rod.

FIG. 96Q-4 illustrates a projecting light emitter-light detector pair.

FIG. 96R-1 illustrates a spring based measuring portion of a sensingrod.

FIG. 96R-2 is a planar view of the spring based measuring portion.

FIG. 96S-1 illustrates a measuring portion having a convex cap.

FIG. 96S-2 illustrates a measuring portion and a sensor arrangement.

FIG. 96S-3 illustrates a flat cap measuring portion.

FIG. 96S-4 illustrates a solid metal cap sensing portion.

FIG. 96T-1 illustrates a sensor arrangement.

FIG. 96T-2 illustrates a detailed view of a wire portion pressing on aspring in the measuring portion.

FIG. 96U is a sectional view of a measuring portion or sensing assembly.

FIG. 96V-1 illustrates a handheld device for measuring biologicalparameters.

FIG. 96V-2 is an alternate perspective view of the handheld device

FIG. 96V-3 illustrates a handheld probe including a sensing tip.

FIG. 96V-4 illustrates a handheld probe including a barrier to infraredlight.

FIG. 96V-5 illustrates a J-shape configuration of the probe.

FIG. 97A illustrates a measuring portion in a sensor connected to awire.

FIG. 97B illustrates a passageway for a sensor and for a wire.

FIG. 97C illustrates a bending of the end of the wire of the sensor.

FIG. 97D illustrates securing of the wire.

FIG. 97E illustrates a plate disposed along the lower portion of ameasuring portion.

FIG. 97F illustrates insertion of a rubberized sleeve and subsequentheat shrinking of the sleeve.

FIG. 97G illustrates a finished sensing device.

FIG. 97H shows an enlarged sensor and wire inserted through apassageway.

FIG. 97J illustrates a measuring portion of a sensing assembly.

FIG. 97K-1 illustrates a wire adjacent to a support structure of asensing assembly.

FIG. 97K-2 illustrates the manufacturing step of attaching a wire to thesupport structure.

FIG. 97L illustrates passing a wire through a slit in a supportstructure.

FIG. 97M-1 illustrates a perforated plate for receiving a measuringportion of a measuring assembly.

FIG. 97M-2 illustrates a measuring portion of a sensing assembly.

FIG. 98A illustrates a handheld radiation detector approaching the faceof a user.

FIG. 99A illustrates a sensing clip for mounting on a pair ofeyeglasses.

FIG. 99B is a side view of the mounting clip shown on FIG. 99A.

FIG. 99C illustrates a sensing clip including a sensor.

FIG. 99D is a side view of the sensing clip shown in FIG. 99C.

FIG. 99E illustrates the sensing clip in an open position.

FIG. 99F illustrates a tension bar in a rest position.

FIG. 99G is a side view of the sensing device shown in FIG. 99F.

FIG. 99H is a side view of the tension bar in an open position.

FIG. 99J illustrates a sensing device to be secured to the frame ofeyeglasses.

FIG. 99K illustrates a sensing device mounted on a pair of eyeglasses.

FIG. 99L illustrates a sensing device clipped to a pair of eyeglasses.

FIG. 99M illustrates a sensing device secured to the frame of a pair ofeyeglasses.

FIG. 99N-1 is a side view of a sensing device.

FIG. 99N-2 is a front view of the sensing clip device of FIG. 99N-1.

FIG. 99N-3 illustrates the mounting of the sensing clip device on a pairof eyeglasses.

FIG. 99P is a front view of a dual sensing clip and its interaction witha plurality of devices.

FIG. 110A illustrates a headband receiving a housing removably attachedto the headband.

FIG. 100B illustrates a detailed view of a brain temperature tunneltemperature module.

FIG. 100C illustrates the wearing of a sensing modular headband.

FIG. 100D illustrates an alternate embodiment of a sensing modularheadband.

FIG. 100E illustrates another embodiment of a sensing modular headband.

FIG. 100F illustrates a sensing modular headband having eight biologicparameter modules.

FIG. 100G is a sectional view of a sensing modular headband.

FIG. 100H is a planar view of a sensing modular headband.

FIG. 100J illustrates the disposition of modules on an external surfaceof a sensing modular headband.

FIG. 100K is an external view of a sensing modular headband.

FIG. 100L illustrates an adhesive surface of an internal area of asensing modular headband.

FIG. 100M illustrates a cavity for receiving a module in a sensingmodular headband.

FIG. 100N illustrates a cap worn by a user including a sensing assembly.

FIG. 100P illustrates a cap worn by a user including a sensing assembly.

FIG. 100Q illustrates a cap worn by a user including a sensing assembly.

FIG. 100R illustrates head mounted gear including a sensing assembly.

FIG. 100S illustrates head mounted gear having a light source and asensing assembly.

FIG. 100T illustrates head mounted gear having a sensing visor worn by auser.

FIG. 100U illustrates a sensing enabled shirt.

FIG. 100V illustrates a helmet including a temperature sensor.

FIG. 100X is a sensing frame including seven biologic parameter modules.

FIG. 100Y illustrates a sensing frame worn by a user.

FIG. 100Z illustrates a sensing frame having temples.

FIG. 101 illustrates an infusion pump connected to a temperaturemonitoring system.

FIG. 102 illustrates a portable powering device coupled to a passivesensing device.

FIG. 103A illustrates a sensing device including a measuring portion andan arm.

FIG. 103B illustrates a probe covering for a measuring portion of asensing device.

FIG. 104-A illustrates a non-invasive internal surface measurementprobe.

FIG. 104-B is a planar view of a sensor head.

FIG. 104-C illustrates a handheld portable sensing probe.

FIG. 104-D illustrates a boomerang shaped sensor probe.

FIG. 104-E illustrates the boomerang shaped sensor probe showing thesensor surface of the sensor head.

FIG. 104-F illustrates the boomerang shaped sensor head and itsrelationship to anatomic structures.

FIG. 104-G illustrates a sensor head and handle.

FIG. 104-H illustrates a bulging sensor on the surface of an insulatingmaterial.

FIG. 105 illustrates an alternate embodiment of placement of a sensingassembly by securing a support structure to a cheek of the user.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In describing a preferred embodiment of the invention illustrated in thedrawings, specific terminology will be resorted to for the sake ofclarity. However, the invention is not intended to be limited to thespecific terms so selected, and it is to be understood that eachspecific term includes all technical equivalents which operate in asimilar manner to accomplish a similar purpose.

FIG. 1A shows a thermal infrared image of the human face showing aphysiologic tunnel. The figure shows an image of the end of the braintemperature tunnel (BTT) depicted as white bright spots in the medialcanthal area and the medial half of the upper eyelid. The end of the BTTon the skin has special geometry, borders, and internal areas and themain entry point is located on the supero-medial aspect of the medialcanthal area diametrically in position with the inferior portion of theupper eyelid and 4 mm medial to the medial corner of the eye. From therethe boundary goes down in the medial canthal area diametrically inposition with the medial corner of the eye and within 5 mm down from themedial corner of the eye, and proceeding up to the upper eyelid with thelateral boundary beginning at the mid-part of the upper eyelid as anarrow area and extending laterally in a fan-like shape with thesuperior boundary beginning in the mid-half of the upper eyelid.

The scale indicates the range of temperature found in the human face.The hottest spots are indicated by the brightest white spots and thecoldest areas are black. Temperature between the hottest and coldestareas are seen in different hues in a gray scale. The nose is cold (seenas black) since it is primarily composed of cartilage and bones, andconsequently has a lower blood volume. That is the reason why frostbiteis most common in the nose.

The surrounding periocular area of the upper and lower eyelids (seen asgray) is hotter because of high vascularization and the reduced amountof adipose tissue. The skin underneath the eyelids is very thin and doesnot have adipose tissue either. However, the other conditions necessaryto define a brain temperature tunnel are not present in this area.

The BTT requirements also include the presence of a terminal branch todeliver the total amount of heat, a terminal branch that is a directbranch from a vessel from the brain, a terminal branch that issuperficially located to avoid far-infrared radiation absorption byother structures, and no thermoregulatory arteriovenous shunts. Thus,the BTT, i.e., the skin area in the medial corner of the eye and uppereyelid, is the unique location that can access a brain temperaturetunnel. The skin around the eyelids delivers undisturbed signals forchemical measurements using spectroscopy and is defined as a metabolictunnel with optimal acquisition of signals for chemical evaluation, butnot for evaluation of the total radiant power of the brain.

FIG. 1B is a computer generated thermal infrared color plot image of thehuman face showing in detail the geometry and different areas of thebrain temperature tunnel and surrounding areas. Only few creatures suchas some beetles and rattle snakes can see this type of radiation, butnot humans. The infrared images make the invisible into visible. Thusthe geometry and size of the tunnel can be better quantified. The colorplot of the isothermal lines show the peripheral area of the tunnel inred and the central area in yellow-white with the main entry point atthe end of the BTT located in the supero-medial aspect of the medialcanthal area above the medial canthal tendon.

The main entry point is the area of most optimal signal acquisition. Theimage also shows the symmetry of thermal energy between the two BTTsites. Since other areas including the forehead do not have theaforementioned six characteristics needed to define a BTT, said areashave lower total radiant power seen as light and dark green. Thus theforehead is not suitable to measure total radiant power. The whole nosehas very little radiant power seen as blue and purple areas, and the tipof the nose seen as brown has the lowest temperature of the face. Thus,the nose area is not suitable for measuring biological parameters.

FIG. 2A is a schematic diagram of a physiologic tunnel, moreparticularly a Brain Temperature Tunnel. From a physical standpoint, theBTT is a brain thermal energy tunnel characterized by a high totalradiant power and high heat flow and can be characterized as a BrainThermal Energy tunnel. The tunnel stores thermal energy and provides anundisturbed path for conveying thermal energy from one end of the tunnelin the cavernous sinus inside of the brain to the opposite end on theskin with the thermal energy transferred to the surface of the skin atthe end of the tunnel in the form of far-infrared radiation. High heatflow occurs at the end of tunnel which is characterized by a thininterface, and the heat flow is inversely proportional to the thicknessof the interface.

The total radiated power (P) at the end of the tunnel is defined byP=σ*e*A*T⁴, where σ is the Stefan-Boltzman constant with a valueσ=5.67×10⁻⁸ W·m⁻²·K⁻⁴ and e is the emissivity of the area. Since the endof the tunnel provides an optimal area for radiation, the total powerradiated grows rapidly as the temperature of the brain increases becauseof the T⁴ term in the equation. As demonstrated in the experiments inthe present invention mentioned, the radiated power in the BTT occurredat a faster rate than the radiated power in the tongue and oral cavity.

The BTT site on the skin is a very small area measuring only less than0.5% of the body surface area.

However, this very small skin region of the body provides the area forthe optimal signal acquisition for measuring both physical and chemicalparameters.

FIG. 2A shows the brain 10 with the thermal energy 12 stored in itsbody. The BTT 20 includes the brain 10, the thermal energy 12 stored inthe brain 10, the thermal energy stored in the tunnel 14 and the thermalenergy 16 transferred to the exterior at the end of the tunnel. Thethermal energy 12, 14, 16 is represented by dark arrows of same size andshape. The arrows have the same size indicating undisturbed thermalenergy from one end of the tunnel to the other and characterized byequivalent temperature within the tunnel.

Thermal energy from the sinus cavernous in the brain 10 is transferredto the end of the tunnel 16 and a rapid rate of heat transfer occursthrough the unimpeded cerebral venous blood path. The tunnel also has awall 18 representing the wall of the vasculature storing the thermalenergy with equivalent temperature and serving as a conduit from theinside of the body 10 to the exterior (skin surface) 19 which ends as aterminal vessel 17 transferring the total amount of thermal energy tosaid skin 19.

The skin 19 is very thin and allows high heat flow. The thickness ofskin 19 is negligible compared to the skin 39, 49 in non-tunnel areas 30and 40 respectively. Due to the characteristics of skin 19, high heatflow occurs and thermal equilibrium is achieved rapidly when a sensor isplaced on the skin 19 at the end of the BTT 20.

In other areas of skin in the face and in the body in general, and inthe exemplary non-tunnel areas 30 and 40 of FIG. 2 several interferingphenomena occur besides the lack of direct vasculature connection to thebrain, and includes self-absorption and thermal gradient. 1.Self-absorption: This relates to the phenomena that deep layers oftissue selectively absorb wavelengths of infrared energy prior toemission at the surface. The amount and type of infrared energyself-absorbed is unknown. At the surface those preferred emissions areweak due to self-absorption by the other layers deriving disorderedthermal emission and insignificant spectral characteristic of thesubstance being analyzed being illustratively represented by the varioussize, shapes and orientations of arrows 34 a to 36 g and 44 a to 46 g,of FIG. 2. Self-absorption in non-tunnel areas thus naturally preventsuseful thermal emission for measurement to be delivered at the surface.2. Thermal gradient: there is a thermal gradient with the deeper layersbeing warmer than the superficial layers, illustratively represented bythicker arrows 36 d and 46 d in the deeper layers compared to thinnerarrows 36 e and 46 e located more superficially. There is excessive andhighly variable scattering of photons when passing through variouslayers such as fat and other tissues such as muscles leading to thermalloss.

Contrary to that, the tunnel area 20 is homogeneous with no absorptionof infrared energy and the blood vessels are located on the surface.This allows undisturbed delivery of infrared energy to the surface ofthe skin 19 and to a temperature detector such as an infrared detectorplaced in apposition to said skin 19. In the BTT area there is nothermal gradient since there is only a thin layer of skin 19 withterminal blood vessel 17 directly underneath said thin interface skin19. The thermal energy 16 generated by the terminal blood vessel 17exiting to the surface skin 19 corresponds to the undisturbed brain(true core) temperature of the body. The preferred path for achievingthermal equilibrium with brain tissue temperature is through the centralvenous system which exits the brain and enters the orbit as the superiorophthalmic vein. The arterial blood is 0.2 to 0.3 degrees Celsius lowerwhen compared to the central venous blood, and said arterial blood isnot the actual equivalent of the brain temperature. Thus althougharterial blood may be of interest in certain occasions, the venoussystem is the preferred carrier of thermal energy for measurement ofbrain temperature. Arterial blood temperature may be of interest todetermine possible brain cooling by the arterial blood in certaincircumstances.

Non-tunnel areas 30 and 40 are characterized by the presence of heatabsorbing elements. The non-tunnel areas 30 and 40 are defined by brokenlines characterizing the vulnerability of interference by heat absorbingconstituents and by the disorganized transferring of heat in saidnon-tunnel areas 30 and 40. Various layers and other constituents innon-tunnel areas 30 and 40 selectively absorb infrared energy emitted bythe deeper layers before said energy reaches the surface of skin, andthe different thermal energy and the different areas are represented bythe different shapes and sizes of arrows and arrow heads.

Non-tunnel area 30 can be representative of measuring temperature with asensor on top of the skin anatomically located above the heart 32. Whitearrows 34 represent the thermal energy in the heart 32. Non-tunnel area30 includes the heart 32 and the various blood vessels and its branches36 a, 36 b, 36 c, 36 d storing thermal energy.

Different amounts of heat are transferred and different temperaturesmeasured depending on the location and anatomy of blood vessels 36 a, 36b, 36 c. The blood vessels branch out extensively from the main trunk 34a. The non-tunnel area 30 also includes heat absorbing structures 37such as bone and muscles which thermal energy 34 from the heart 32 needto be traversed to reach the skin 39. The non-tunnel area 30 alsoincludes a variable layer of fat tissue 38 which further absorbs thermalenergy. The reduced amount of thermal energy reaching the skin surface39 due to the presence of fat 38 is represented by the arrows 36 d and36 e, in which arrow 36 d has higher temperature than arrow 36 e.Non-tunnel area 30 also includes a thick skin 39 with low heat flowrepresented by arrows 36 f.

The thick skin 39 corresponds to the skin in the chest area and fatlayer 38 corresponds to the variable amount of fat present in the chestarea. Arrows 36 g represent the disordered and reduced total radiantpower delivered after said thermal energy traverses the interferingconstituents in the non-tunnel area including a thick interface and heatabsorbing structures. In addition, BTT 20 has no fat layer as found innon-tunnel areas 30 and 40. Lack of a thick interface such as thick skinand fat, lack of thermal barriers such as fat, and lack of heatabsorbing elements such as muscles allows undisturbed emission ofradiation at the end of the BTT. Lack of a thick interface such as thickskin and fat, lack of thermal barriers such as fat, and lack of heatabsorbing elements such as muscles allowed undisturbed emission ofradiation at the end of the BTT.

Yet referring to FIG. 2, non-tunnel area 40 can be representative ofmeasuring temperature with a sensor on top of the skin in the arm 42.The heat transfer in non-tunnel area 40 has some similarity withnon-tunnel area 30 in which the end result is a disordered and reducedtotal radiant power not representative of the temperature at theopposite end internally. The blood vessels branch out extensively fromthe main trunk 44 a. Thermal energy and temperature in blood vessels 46a, 46 b, 46 c is different than in areas 36 a, 36 b, 36 c. Thestructures that thermal energy 44 needs to traverse to reach the skinare also different compared to non-tunnel 30. The amount of heatabsorbing structures 47 is different and thus the end temperature atnon-tunnel 40 is also different when compared to non-tunnel area 30. Theamount of fat 48 also varies which changes the energy in areas 46 d and46 e, wherein area 46 d is deeper than area 46 e. Thick skin 49 alsoreduces heat flow and the temperature of the area 46 f. Reduction ofradiant power indicated by arrow 46 g when compared to radiant power 36g is usually quite different, so different skin temperature is measureddepending on the area of the body. This applies to the whole skinsurface of the body, with the exception of the skin at the end of theBTT.

Measurements of internal temperature such as rectal do not have the sameclinical relevance as measurement in the brain. Selective brain coolinghas been demonstrated in a number of mammalian species under laboratoryconditions and the same process could occur in humans. For instance thetemperature in bladder and rectum may be quite different than the brain.High or low temperature in the brain may not be reflected in thetemperature measured in other internal organs.

FIG. 2B is a cross-sectional schematic diagram of the human head 9showing the brain 10, spinal cord 10 a, the tunnel 20 represented by thesuperior ophthalmic vein, the cavernous sinus 1, which is the thermalenergy storage compartment for the brain, and the various insulatingbarriers 2, 2 a, 3, 4, 4 a, 4 b, 5 that keep the brain as a completelythermally insulated structure. Insulating barriers include skin 2corresponding to the scalp, skin 2 a corresponding to the skin coveringthe face, fat 3 covering the whole surface of the skull and face, skullbone 4, spinal bone 4 a surrounding spinal cord 10 a, facial bone 4 bcovering the face, and cerebral spinal fluid (CSF) 5. The combinedthickness of barriers 2,3,4,5 insulating the brain can reach 1.5 cm to2.0 cm, which is a notable thickness and the largest single barrieragainst the environment in the whole body. Due to this completelyconfined environment the brain cannot remove heat efficiently and heatloss occurs at a very low rate. Skin 2 corresponds to the scalp which isthe skin and associated structure covering the skull and which has lowthermal conductivity and works as an insulator. Fat tissue 3 absorbs themajority of the far-infrared wavelength and works as a thermal buffer.Skull bone 4 has low thermal conductivity and the CSF works as aphysical buffer and has zero heat production.

The heat generated by metabolic rate in the brain corresponds to 20% ofthe total heat produced by the body and this enormous amount of heat iskept in a confined and thermally sealed space. Brain tissue is the mostsusceptible tissue to thermal energy induced damage, both high and lowlevels of thermal energy. Because of the thermal insulation and physicalinability of the brain to gain heat or lose heat, both hypothermic(cold) and hyperthermic (hot) states can lead to brain damage and deathcan rapidly ensue, as occur to thousands of healthy people annuallybesides seizures and death due to high fever in sick people. Unlessappropriate and timely warning is provided by continuously monitoringbrain temperature anyone affected by cold or hot disturbances is at riskof thermal induced damage to the brain.

FIG. 2B also shows a notably small entry point 20 a measuring less than0.5% of the body surface which corresponds to the end of the tunnel 20on the skin 2 b. The skin 2 b is extremely thin with a thickness of 1 mmor less compared to the skin 2 and 2 a which are five fold or more,thicker than skin 2 b.

The tunnel 20 starts at the cavernous sinus 1 which is a conduit forvenous drainage for the brain and for heat transfer at the end of thetunnel 20 as a radiant energy. Tunnel 20 provides an unobstructedpassage to the cavernous sinus 1, a structure located in the middle ofthe brain, and which is in direct contact with the two sources of heatto the brain: 1) thermal energy produced due to metabolic rate by thebrain and carried by the venous system; and 2) thermal energy deliveredby the arterial supply from the rest of the body to the brain. Thisdirect contact arrangement is showed in detail in FIG. 2C, which is acoronal section of FIG. 2B corresponding to the line marked “A”.

FIG. 2C is a coronal section through the cavernous sinus 1 which is acavity-like structure with multiple spaces 1 a filled with venous bloodfrom the veins 9 and from the superior ophthalmic vein 6. Cavernoussinus 1 collects thermal energy from brain tissue 7, from arterial bloodof the right and left internal carotid arteries 8 a, 8 b, and fromvenous blood from vein 9. All of the structures 7, 8 a, 8 b, 9 aredisposed along and in intimate contact with the cavernous sinus 1. Aparticular feature that makes the cavernous sinus 1 of the tunnel a veryuseful gauge for temperature disturbances is the intimate associationwith the carotid arteries 8 a, 8 b. The carotid arteries carry the bloodfrom the body, and the amount of thermal energy delivered to the brainby said vessels can lead to a state of hypothermia or hyperthermia. Forinstance during exposure to cold, the body is cold and cold blood fromthe body is carried to the brain by internal carotid arteries 8 a, 8 b,and the cavernous sinus 1 is the entry point of those vessels 8 a, 8 bto the brain.

As soon as cold blood reaches the cavernous sinus 1 the correspondingthermal energy state is transferred to the tunnel and to the skinsurface at the end of the tunnel, providing therefore an immediate alerteven before the cold blood is distributed throughout the brain. The sameapplies to hot blood for instance generated during exercise which canlead to a 20 fold heat production compared to baseline. This heatcarried by vessels 8 a, 8 b is transferred to the cavernous sinus 1 andcan be measured at the end of the tunnel. In addition, the thermalenergy generated by the brain is carried by cerebral venous blood andthe cavernous sinus 1 is a structure filled with venous blood.

FIG. 3A is a thermal infrared image of the human face in which thegeometry of the end of the tunnel on the skin can be visualized. Thewhite bright spots define the central area of the tunnel. FIG. 3B is aschematic diagram of an exemplary geometry on the skin surface at theend of the tunnel. The medial aspect 52 of the tunnel 50 has a roundshape. The lateral aspect 54 borders the upper lid margin 58 andcaruncle 56 of the eye 60. The tunnel extends from the medial canthalarea 52 into the upper eyelid 62 in a horn like projection.

The internal areas of the tunnel 50 include the general area for themain entry point and the main entry point as shown in FIGS. 4A to 5D.FIG. 4A is a thermal infrared image of the side of the human faceshowing a general view of the main entry point of the brain temperaturetunnel, seen as white bright points located medial and above the medialcanthal corner. FIG. 4B is a diagram showing the general area 70 of themain entry point and its relationship to the eye 60, medial canthalcorner 61, eyebrow 64, and nose 66. The general area 70 of the mainentry point provides an area with more faithful reproduction of thebrain temperature since the area 70 has less interfering elements thanthe peripheral area of the tunnel.

FIG. 5A is a thermal infrared image of the front of the human face withthe right eye closed showing the main entry point of the braintemperature tunnel seen as white bright spots above and medial to themedial canthal corner. With closed eyes it is easy to observe that theradiant power is coming solely from the skin at the end of BTT.

FIG. 5B is a diagram showing the main entry point 80 and itsrelationship to the medial canthal corner 61 of closed eye 60 andeyelids 62. The main entry point 80 of the tunnel provides the area withthe most faithful reproduction of the brain temperature since the area80 has the least amount of interfering elements and is universallypresent in all human beings at an equivalent anatomical position. Themain entry point 80 has the highest total radiant power and has asurface with high emissivity. The main entry point 80 is located on theskin in the superior aspect of the medial canthal area 63, in thesupero-medial aspect of the medial canthal corner 61.

FIG. 5C is a thermal infrared image of the side of the human face inFIG. 5A with the left eye closed showing a side view of the main entrypoint of the brain temperature tunnel, seen as bright white spots. Itcan be observed with closed eyes that the radiant power is coming solelyfrom the skin at the end of BTT.

FIG. 5D shows the main entry point 80 in the superior aspect of themedial canthal area above the medial canthal corner 61, and also showsthe position of main entry point 80 in relation to the eye 60, eyebrow64 and nose 66. Support structures can precisely position sensingdevices on top of the main entry point of the tunnel because the mainentry point is completely demarcated by anatomic landmarks. In generalthe sensor is positioned on the medial canthal skin area above themedial canthal corner and adjacent to the eye. Although indicators canbe placed on support structures to better guide the positioning of thesensor, the universal presence of the various permanent anatomiclandmarks allows the precise positioning by any non-technical person.

The main entry point is the preferred location for the positioning ofthe sensor by the support structure, but the placement of a sensor inany part of the end of the tunnel including the general entry point areaand peripheral area provides clinically useful measurements depending onthe application. The degree of precision needed for the measurement willdetermine the positioning of the sensor. In cases of neurosurgery,cardiovascular surgery, or other surgical procedures in which thepatient is at high risk of hypothermia or malignant hyperthermia, thepreferred position of the sensor is at the main entry point. Forrecreational or professional sports, military, workers, fever detectionat home, wrinkle protection in sunlight, and the like, positioning thesensor in any part of the end of the tunnel area provides the precisionneeded for clinical usefulness.

In accordance with the present invention, FIG. 6 is a schematic view ofthe face showing the general area of the main entry point of the tunnel90 and the overall area of the end of the tunnel and its relationship tothe medial canthal tendon 67. The end of the tunnel includes the generalmain entry point area 90 and the upper eyelid area 94. The area 90 has aperipheral portion 92. Both medial canthal areas have a medial canthaltendon and the left eye is used to facilitate the illustration. Themedial canthal tendon 67 arises at the medial canthal corner 61 of eye60. The left medial canthal tendon 67 is diametrically opposed to theright medial canthal tendon as shown by broken lines 61 a which beginsat the medial corner of the eye 61. Although the main entry point isabove the medial canthal tendon 67, some of the peripheral area 92 ofthe tunnel is located below tendon 67.

FIG. 6A is a schematic diagram showing two physiologic tunnels. Theupper figure shows the area corresponding to the BTT 10. The lowerfigure shows an area corresponding to a metabolic tunnel 13 whichincludes the upper eyelid area 13 a and lower eyelid area 13 b seen aslight blue areas in FIG. 1B. For measuring the concentration of chemicalsubstances the total radiant power is not mandatory. The key aspect forclinical useful spectroscopic measurements is signal coming from thecerebral area and the reduction or elimination of interferingconstituents, and the main interfering constituent is adipose tissue. Byremoving adipose tissue and receiving spectral information carried by avasculature from the brain, precise and clinical measurements can beachieved. The sensors supported by support structure are adapted to havea field of view that matches in total or in part the metabolic tunnel 13for capturing thermal radiation from said tunnel 13.

To determine the thermal stability of the tunnel area in relation toenvironmental changes, cold and heat challenge tests were performed.FIGS. 7A and 7B are thermal infrared images of an exemplary experimentshowing the human face before and after cold challenge. In FIG. 7A theface has a lighter appearance when compared to FIG. 7B which is darkerindicating a lower temperature. The nose in FIG. 7A has an overallwhitish appearance as compared to the nose in FIG. 7B which has anoverall darker appearance. Since the areas outside the tunnel havethermoregulatory arteriovenous shunts and interfering constituentsincluding fat, the changes in the temperature of the environment arereflected in said areas. Thus measurements in those non-tunnel areas ofthe face reflect the environment instead of the actual body temperature.The non-tunnel areas of the skin in the face and body can change withthe changes in ambient temperature. The radiant power of the tunnel arearemains stable and there is no change in the amount of thermal energydemonstrating the stability of the thermal emission of the BTT area.Changes of thermal radiation at the tunnel area only occur when thebrain temperature changes, which provides the most reliable measurementof the thermal status of the body.

FIGS. 8A and 8B are thermal infrared images of the human face ofdifferent subjects showing the tunnel seen as bright white spots in themedial canthal area. The physiologic tunnel is universally present inall individuals despite anatomic variations and ethnic differences.FIGS. 9A and 9B are thermal infrared image showing that the tunnel seenas bright white spots are equally present in animals, illustrated hereby a cat (FIG. 9A) and a dog (FIG. 9B).

A preferred embodiment includes a temperature sensor with measurementprocessing electronics housed in a patch-like support structure whichpositions a passive sensor directly in contact with the skin over thebrain temperature tunnel site. Accordingly, FIG. 10 is a perspectiveview of a preferred embodiment showing a person 100 wearing a supportstructure comprised of a patch 72 with a passive sensor 74 positioned onthe skin at the end of the tunnel. Person 100 is laying on a mattress 76which contains antenna 78. Wire 82 extends from antenna 78 to controllerunit 84 with said controller 84 communicating with device 88 bycommunication line 86. Exemplary device 88 includes a decoding anddisplay unit at the bedside or at the nursing station. It is understoodthat controller unit 84 besides communicating by cable 86, can alsocontain a wireless transmission device to wirelessly transmit the signalacquired to a remote station. This inductive radio frequency poweredtelemetry system can use the same antenna 78 to transfer energy and toreceive the signal.

The antenna 78 can be secured to a mattress, pillow, frame of a bed, andthe like in a removable or permanent manner. The preferred embodimentincludes a thin flat antenna encapsulated by a flexible polymer that issecured to a mattress and is not visible to the user. Alternatively anantenna can be placed in any area surrounding the patient, such as on anight stand.

The antenna 78 and controller unit 84 works as a receiver/interrogator.A receiver/interrogator antenna 78 causes RF energy to radiate to themicrocircuit in the patch 72. This energy would be stored and convertedfor use in the temperature measurement process and in the transmissionof the data from the patch 72 to the antenna 78. Once sufficient energyhas been transferred, the microcircuit makes the measurement andtransmits that data to the receiver/interrogator antenna 78 with saiddata being processed at controller 84 and further communicated to device88 for display or further transmission. The switching elements involvedin the acquisition of the sensor data (measurement of the energy) isdone in a sequence so that the quantitized answer is available andstored prior to the activation of the noise-rich transmission signal.Thus the two inherently incompatible processes successfully coexistbecause they are not active simultaneously.

The capability of the RF link to communicate in the presence of noise isaccomplished by “spreading” the spectral content of the transmittedenergy in a way that would inherently add redundancy to the transmissionwhile reducing the probability that the transmission can ever beinterpreted by the receiver/interrogator 78 as another transmission ornoise that would cause the receiver/interrogator 78 to transmit anddisplay incorrect information. This wireless transmission scheme can beimplemented with very few active elements. The modulation purposelyspreads the transmission energy across the spectrum and thus providesnoise immunity and the system can be ultimately produced via batchprocessing and thus at a very low cost.

Since the energy to operate sensor 74 in patch 72 comes from the antenna78, the microcircuit in said patch 72 can be very small and ultra-thin.Size of the patch 72 would be further minimized to extremely smalldimensions by the design approach that places all the processingfunction of the RF link in the controller unit 84 working as a receiver.RF messaging protocol and the control of the sensor 74 resides in thereceiver/interrogator controller 84 powered by commercially availablebatteries or by AC current. Thus the RF messaging protocol and thecontrol of the sensor 74 is directly controlled by the MCU of controller84. The circuit resident in the patch 72 is preferably completelyself-contained. The sensing system 74 in the patch 72 is preferably asilicon microcircuit containing the circuits needed to support thesensor, quantatize the data from the sensor, encode the data for radiofrequency transmission, and transmit the data, besides powerconditioning circuits and digital state control. Sensor, supportcircuitry, RF power and communications are all deposited on a micro-chipdie allowing the circuit to be built in large quantities and at very lowcost. This scheme is preferably used for both passive and activedevices.

The operational process can consist of two modes, manual or automated.In the manual mode, an operator such as a nurse activates the system andRF energy radiated to the microcircuit in the patch 72 would be storedand converted for use in the temperature measurement process and in thetransmission of the data from the end of the BTT to the antenna 78. Oncesufficient energy has been transferred (less than 1 second) themicrocircuit would make the measurement and transmit the data to theantenna 78 receiver and controller 84 to be displayed for example on aback-lit LCD display at the nursing station. An audio “beep” will signalthat the data had been received and is ready for view. In the automatedmode, the process is done automatically and continuously byinterrogation at preset frequency and an alarm being activated when thereading is outside the specified range. A tri-dimensional antenna canalso be used and the controller 84 set up to search the three dimensionsof the antenna to assure continued and proper connection between antenna78 and sensing means 74. It is also understood that the sensor canmodulate reflected RF energy. Accordingly, the energy will trigger theunit to acquire a temperature measurement, and then the unit willmodulate the reflected energy. This reflected energy and informationwill be received at the interrogator and displayed as above.

The present invention also provides a method for monitoring biologicalparameters, which comprises the steps of: securing a passive sensor tothe body; generating electromagnetic radiation from a device secured toat least one of a mattress, a pillow and the frame of a bed; generatinga signal from said passive sensor; receiving said signal by a devicesecured to at least one of a mattress, a pillow and the frame of a bed;and determining the value of the biological parameter based on saidsignal.

It is understood that a variety of external power sources such aselectromagnetic coupling can be used including an ultra-capacitorcharged externally through electromagnetic induction coupling and cellsthat can be recharged by an external oscillator. It is also understoodthat the sensing system can be remotely driven by ultrasonic waves.

FIG. 11 is a perspective view of another preferred embodiment showing incloser detail a person 100 wearing a support structure comprised ofpatch 72 with a sensor 74, transmitter 71, and digital converter andcontrol 73 positioned on the skin at the end of the tunnel. Person 100is wearing a necklace which works as antenna 78 and a pendant in thenecklace works as the controller unit and transmitting unit 79. Solarcells and/or specialized batteries power unit 79. Patients are used tocarrying Holter monitoring and cards with cords around their necks andthis embodiment can fit well with those currently used systems. It isunderstood that, besides a necklace, a variety of articles includingclothing and electric devices can be used as a receiver/interrogator andthis capability can be easily incorporated into cell phones, note bookcomputers, hand held computers, internet appliances for connecting tothe internet, and the like, so a patient could use his/her cell phone orcomputer means to monitor his/her brain temperature.

The preferred embodiments shown in FIGS. 10 and 11 can preferablyprovide continuous monitoring of fever or temperature spikes for anysurgery, for any patient admitted to a hospital, for nursing homepatients, in ambulances, and to prevent death or harm by hospitalinfection. Hospital infection is an infection acquired during a hospitalstay. Hospital infection is the fourth cause of death in the U.S. andkills more than 100,000 patients annually and occurs primarily due tolack of early identification of fever or temperature spikes. The presentinvention provides timely identification and therapy of an infection dueto 24 hour automated monitoring of temperature. If there is a spike intemperature an alarm can be activated. This will allow timelyidentification and treatment of an infection and thus prevent death orcostly complications such as septic shock that can occur due to delay intreating infectious processes. Besides, said preferred embodimentsprovide means for continuous fever monitoring at home including duringsleeping for both children and adults.

FIG. 12A is a front perspective view of a preferred embodiment showing aperson 100 wearing a support structure comprised of a patch 109 withindicator lines 111 and containing an active sensor 102 positioned onthe skin at the end of the tunnel. The preferred embodiment shown inFIG. 12 provides a transmitting device 104, a processing device 106, ADconverter 107 and a sensing device 102 connected by flexible circuit 110to power source 108. For example the transmitting module can include RF,sound or light. FIG. 12B is a side schematic view showing the flexiblenature of the support structure in FIG. 12A with flexible circuit 110connecting microelectronic package 103 which contains a transmittingdevice means, a processing device and a sensing device in the right sideof the patch 109 and the power source 108 in the left side of said patch109. Exemplary embodiments will be described.

In accordance with this exemplary embodiment for temperaturemeasurement, the thermal energy emitted by the BTT is sensed by thetemperature sensor 102 such as a miniature thermistor which produces asignal representing the thermal energy sensed. The signal is thenconverted to digital information and processed by processor 106 usingstandard processing for determining the temperature. An exemplarysonic-based system for brain temperature measurement comprises atemperature sensor, input coupling circuit, signal processing circuit,output coupling circuit and output display circuit. A temperature sensor102 (e.g., thermistor) in a patch 109 placed on the surface of the skinat the medial canthal area responds to variations in brain temperaturewhich is manifested as a DC voltage signal.

This signal, coupled to a Signal Processor Circuit via an Input CouplingCircuit is used to modulate the output of an oscillator, e.g., amultivibrator circuit, piezoelectric systems operating in or just abovethe audio frequency range. The oscillator is a primary component of theSignal Processor Circuit. The output of the oscillator is input to anamplifier, which is the second primary component of the SignalProcessor.

The amplifier increases the output level from the oscillator so that theoutput of the Signal Processor is sufficient to drive an Output DisplayCircuit. Depending on the nature of the Output Display Circuit, e.g., anaudio speaker, a visual LED display, or other possible displayembodiment, an Output Coupling Circuit is utilized to match the signalfrom the Signal Processor Circuit to the Output Display Circuit. For anOutput Display Circuit that requires a digital input signal, the OutputCoupling Circuit might include an analog to digital (A/D) convertercircuit. A DC power supply circuit is the remaining primary component inthe Signal Processor Module. The DC power supply is required to supportthe operation of the oscillator and the amplifier in the SignalProcessing Circuit. Embodiments of the DC power supply can include ultraminiature DC batteries, a light sensitive DC power source, or somecombination of the two, and the like. The micro transducers, signalprocessing electronics, transmitters and power source can be preferablyconstructed as an Application Specific Integrated Circuit or as a hybridcircuit alone or in combination with MEMS (micro electrical mechanicalsystems) technology.

The thermistor voltage is input to a microcontroller unit, i.e., asingle chip microprocessor, which is pre-programmed to process thethermistor voltage into a digital signal which corresponds to thepatient's measured temperature in degrees C. (or degrees F.) at the BTTsite. It is understood that different programming and schemes can beused. For example, the sensor voltage can be directly fed into themicrocontroller for conversion to a temperature value and then displayedon a screen as a temperature value, e.g., 98.6° F. On the other hand thevoltage can be processed through an analog to digital converter (ADC)before it is input to the microcontroller.

The microcontroller output, after additional signal conditioning, servesas the driver for a piezoelectric audio frequency (ultrasonic)transmitter. The piezoelectric transmitter wirelessly sends digitalpulses that can be recognized by software in a clock radio sizedreceiver module consisting of a microphone, low-pass audio filter,amplifier, microcontroller unit, local temperature display andpre-selected temperature level alert mechanism. The signal processingsoftware is pre-programmed into the microcontroller unit of thereceiver. Although the present invention provides means for RFtransmission in the presence of noise, this particular embodiment usinga microphone as the receiving unit may offer additional advantages inthe hospital setting since there is zero RF interference with the manyother RF devices usually present in said setting. The microcontrollerunit drives a temperature display for each patient being monitored. Eachtransmitter is tagged with its own ID. Thus one receiver module can beused for various patients. A watch, cell phone, and the like adaptedwith a microphone can also work as the receiver module.

In another embodiment the output of the microcontroller is used to drivea piezo-electric buzzer. The microcontroller output drives thepiezo-electric buzzer to alert the user of the health threateningsituation. In this design the output of the microcontroller may be fedinto a digital-to-analog converter (DAC) that transforms the digitaldata signal from the microcontroller to an equivalent analog signalwhich is used to drive the buzzer.

In yet another embodiment the output from the (DAC) is used to drive aspeech synthesizer chip programmed to output an appropriate audiowarning to the user, for instance an athlete at risk of heatstroke. Fora sensed temperature above 39 degrees Celsius the message might be:“Your Body temperature is High. Seek shade. Drink cold liquid. Rest.”For temperature below 36 degrees Celsius the message might be: “YourBody temperature is Low. Seek shelter from the Cold. Drink warm liquid.Warm up.”

In another embodiment the output is used to drive a light transmitterprogrammed to output an appropriate light signal. The transmitterconsists of an infrared light that is activated when the temperaturereaches a certain level. The light signal will work as a remote controlunit that activates a remote unit that sounds an alarm. This embodimentfor instance can alert the parents during the night when the child issleeping and has a temperature spike.

An exemplary embodiment of the platform for local reporting consists ofthree electronic modules mechanically housed in a fabric or plasticholder such as patch 109, which contain a sensor 102 positioned on theskin at the BTT site. The modules are: Temperature Sensor Module,Microcontroller Module, and Output Display Module in addition to abattery. An electronic interface is used between each module for theoverall device to properly function. The configuration of this systemconsists of a strip such as patch 109 attached to the BTT area by aself-adhesive pad. A thermistor coupled to a microcontroller drives anaudio frequency piezoelectric transmitter or LED. The system provideslocal reporting of temperature without a receiver. An audio tone orlight will alert the user when certain thresholds are met. The tone canwork as a chime or reproduction of human voice.

Another exemplary embodiment for remote reporting consists of fourelectronic modules: Sensor Module, Microcontroller Module, OutputTransmitter Module and Receiver/Monitor Module. From a mechanicalviewpoint the first three modules are virtually identical to the firstembodiment. Electronically the Temperature Sensor and MicroprocessorModules are identical to the previous embodiment. In this embodiment anOutput Transmitter Module replaces the previous local Output DisplayModule. Output Transmitter Module is designed to transmit wirelessly thetemperature results determined by the Microprocessor Module to aremotely located Receiver/Monitor Module. An electronic interface isused between each module for proper function. This device can beutilized by patients in a hospital or home setting. On a continuousbasis temperature levels can be obtained by accessing data provided bythe Receiver/Monitor Module.

A variety of temperature sensing elements can be used as a temperaturesensor including a thermistor, thermocouple, or RTD (ResistanceTemperature Detector), platinum wire, surface mounted sensors,semiconductors, thermoelectric systems which measure surfacetemperature, optic fiber which fluoresces, bimetallic devices, liquidexpansion devices, and change-of-state devices, heat flux sensor,crystal thermometry and reversible temperature indicators includingliquid crystal Mylar sheets. A preferred temperature sensor includesthermistor model 104JT available from Shibaura of Japan.

FIG. 13 shows a block diagram of a preferred embodiment of the presentinvention linking transmitter 120 to receiver 130. Transmitter 120preferably includes a chip 112 incorporating a microcontroller (MCU)114, a radio frequency transmitter (RF) 116 and a A/D converter 118 inaddition to a power source 122, amplifier (A) 124, sensor 126, andantenna 128, preferably built-in in the chip. Exemplary chips include:(1) rfPIC12F675F, (available from Microchip Corporation, Arizona, USA)this is a MCU+ADC+433 Mhz Transmitter (2) CC1010, available from ChipconCorporation of Norway.

Receiver 130 preferably includes a chip RF transceiver 132 (e.g., CC1000available from Chipcon Corporation), a microcontroller unit (MCU) 134,amplifier and filtering units (A/F) 136, display 138, clock 140, keypad142, LED 144, speaker 146, in addition to a power source 150 andinput/output units (I/O) 148 and associated modem 152, opticaltransceiver 154 and communication ports 156.

A variety of devices can be used for the transmission scheme besides thecommercially available RF transmitter chips previously mentioned. Onesimple transmission devices include an apparatus with a single channeltransmitter in the 916.48 MHz band that sends the temperature readingsto a bed side receiver as a frequency proportional to the reading. Thethermistor's resistance would control the frequency of an oscillatorfeeding the RF transmitter data input. If the duty cycle is less than1%, the 318 MHz band would be usable. Rather than frequency, a periodmeasurement technique can be used. The model uses a simple radiofrequency carrier as the information transport and modulating thatcarrier with the brain temperature information derived from atransduction device capable of changing its electrical characteristicsas a function of temperature (e.g.; thermistor). Either frequency oramplitude of the carrier would be modulated by the temperatureinformation so that a receiver tuned to that frequency could demodulatethe changing carrier and recover the slowly moving temperature data.

Another transmission technique suitable to transmit the signal from asensor in a support structure is a chirp device. This means that whenactivated, the transmitter outputs a carrier that starts at a lowerfrequency in the ISM band and smoothly increases frequency with timeuntil a maximum frequency is reached. The brain temperature informationis used to modify the rate of change of frequency of the chirp. Thereceiver is designed to measure the chirp input very accurately bylooking for two or more specific frequencies. When the first of thefrequencies is detected, a clock measures the elapsed time until thesecond frequency is received. Accordingly, a third, fourth, etc.,frequency could be added to aid in the rejection of noise. Sincevirtually all the direct sequence spread spectrum transmitters andfrequency hopping transmitters are spread randomly throughout their partof the ISM band, the probability of them actually producing the “right”sequence of frequencies at exactly the right time is remote.

Once the receiver measured the timing between the target frequencies,that time is the value that would represent the brain temperature. Ifthe expected second, third, or fourth frequency is not received by thereceiver within a “known” time window, the receiver rejects the initialinputs as noise. This provides a spread spectrum system by using a widespectrum for transmitting the information while encoding the informationin a way that is unlike the expected noise from other users of the ISMband. The chirp transmitter is low cost and simple to build and thebrain temperature transducer is one of the active elements that controlsthe rate of change of frequency.

Other preferred embodiments for local reporting include a sensor, anoperational amplifier (LM358 available from National SemiconductorCorporation) and a LED in addition to a power source. It is understoodthat the operational amplifier (Op Amp) can be substituted by a MCU andthe LED substituted by a piezoelectric component.

FIG. 14 is a schematic diagram showing the support structure 160 to asensor 158, and MCU 164 controlling and/or adjusting unit 162.Communication between MCU 164 and unit 162 is achieved by wires 168 orwirelessly 166. By way of example, but not by limitation, exemplaryunits 162 include climate control units in cars, thermostats, vehicleseats, furniture, exercise machines, clothing, footwear, medicaldevices, drug pumps, and the like. For example, MCU 164 is programmedwith transmit the temperature level to receiver unit 162 in the exercisemachine. MCU in the exercising machine unit 162 is programmed to adjustspeed or other settings in accordance with the signal generated by MCU164.

The preferred embodiment allows precise positioning of the sensingapparatus by the support structure on the BTT site. The supportstructure is designed to conform to the anatomical landmarks of the BTTarea which assures proper placement of the sensor at all times. Thecorner of the eye is considered a permanent anatomic landmark, i.e., itis present in the same location in all human beings. The BTT area isalso a permanent anatomic landmark as demonstrated by the presentinvention. To facilitate consistent placement at the BTT site, anindicator in the support structure can be used as shown in FIGS. 15A to15E.

FIG. 15A shows a Guiding Line 170 placed on the outside surface of thesupport structure 172. The Guiding Line 170 is lined up with the medialcorner of the eye 174. The sensor 176 is located above the Guiding Line170 and on the outer edge of the support structure 172, so once theGuiding Line 170 of the support structure 172 is lined up with themedial corner of the eye 174, the sensor 176 is positioned on the mainentry point of the tunnel. Thus the support structure 172 can beprecisely and consistently applied in a way to allow the sensor 176 tocover the BTT area at all times.

FIG. 15B shows a different design of the patch 172 but with the sameGuiding Line 170 lined up with the medial corner of the eye 174, thusallowing consistent placement of sensor 176 at the BTT site despite thedifference in design.

FIG. 15C is another preferred embodiment showing the sensor 176 lined upwith medial corner 174. Thus in this embodiment a Guiding Line is notrequired and the sensor 176 itself guides the positioning.

In FIG. 15D the MCU 175 and cell 177 of patch 172 are located outside ofthe BTT site while sensor 176 is precisely positioned at the BTT site.It is understood that any type of indicator on the support structure canbe used to allow proper placement in the BTT area including externalmarks, leaflets, cuts in the support structure, different geometry thatlines up with the corner of the eye, and the like.

FIG. 15E is another preferred embodiment showing the superior edge 176 aof sensor 176 lined up with medial corner 174 and located in theinferior aspect of the medial canthal area while microchip controller175 is located in the superior aspect of the medial canthal area.Support structure 172 has a geometric indicator 179 comprised of a smallrecess on the support structure 172. It is understood that a stripworking as support structure like an adhesive bandage can have the sideopposite to the sensor and hardware made with tear off pieces. Thesensor side is first attached to the skin and any excess strip can beeasily torn off. Two sizes, adult and children cover all potentialusers.

The material for the support structure working as a patch can be softand have insulating properties such as are found in polyethylene.Depending on the application a multilayer structure of the patch caninclude from the external side to the skin side the following:thinsulate layer; double foam adhesive (polyethylene); sensor(thermistor); and a Mylar sheet. The sensor surface can be covered bythe Mylar sheet, which in turn is surrounded by the adhesive side of thefoam. Any soft thin material with high thermal resistance and lowthermal conductivity can be preferably used as an interface between thesensor and the exterior, such as polyurethane foam (K=0.02 W/m·C). Anysupport structure can incorporate the preferred insulation material.

A preferred power source for the patch includes natural thermoelectricsas disclosed by the present invention. In addition, standard lightweightthin plastic batteries using a combination of plastics such asfluorophenylthiophenes as electrodes can be used, and are flexibleallowing better conformation with the anatomy of the BTT site. Anotherexemplary suitable power source includes a light weight ultra-thin solidstate lithium battery comprised of a semisolid plastic electrolyte whichare about 300 microns thick.

The system can have two modes: at room temperature the system is quietand at body temperature the system is activated. The system can alsohave an on/off switch by creating a circuit using skin resistance, soonly when the sensor is placed on the skin is the system activated. Thepatch can also have a built-in switch in which peeling off a conductivebacking opens the circuit (pads) and turn the system on. In addition,when removed from the body, the patch can be placed in a case containinga magnet. The magnet in the case acts as an off switch and transmissionis terminated when said patch is in the case.

FIG. 16A to 16C are perspective views of preferred embodiments showing aperson 100 wearing support structures 180 incorporated as patches. In apreferred embodiment shown in FIG. 16A, the support structure 180contains LED 184, cell 186, and sensor 182. Sensor 182 is positioned ata main entry point on the superior aspect of the medial canthal areaadjacent to the medial corner of the eye 25. LED 184 is activated when asignal reaches certain thresholds in accordance with the principles ofthe invention. FIG. 16B is another preferred embodiment showing a person100 wearing support structure 180 with sensor 182 positioned at thegeneral area of the main entry point of the tunnel with the superioredge 181 of support structure 180 being lined up with the corner of theeye 25. Support structure 180 contains an extension that rests on thecheek area 189 and houses transmitting means 183 for wirelesstransmission, processing means 185 and power source 187. FIG. 16C is anexemplary preferred embodiment showing person 100 wearing a two piecestructure 180 a comprised of support structure 180 b and housingstructure 180 c connected by wires 192, preferably a flexible circuit.Support structure 180 b contains the sensor 182 which is positioned atthe BTT site. Housing structure 180 c which can comprise an adhesivestrip on the forehead 21 houses processing device 183 a, transmittingdevice 183 b and power source 187 for transmitting the signal to unit194, for example a cell phone.

FIG. 17 is a schematic view of another preferred embodiment showing thesupport structure 180 with sensor 182 being held at the nose 191 by aclip 196. Support structure 180 extends superiorly to the forehead 193.Housing 195 of support structure 180 contains pressure attachment meanssuch as clip 196. Housing 197 on the forehead contains the transmittingdevice and power source. Clip 196 uses a spring based structure 196 a toapply gentle pressure to secure support structure 180 and sensor 182 ina stable position. Housing 197 can also have a LCD display 19. The LCD19 can have an inverted image to be viewed in a mirror by the user,besides LCD 19 can have a hinge or be foldable to allow properpositioning to allow the user to easily view the numerical valuedisplayed.

FIG. 18 is a perspective view of another preferred embodiment showing aperson 100 wearing a support structure 180 comprised of a patch withsensor 182 positioned on the skin at the end of the tunnel and connectedby a wire 199 to a decoding and display unit 200. Support structure 180has a visible indicator 170 lined up with the medial corner of the eye174. Wire 199 includes an adhesive tape 201 within its first 20 cm, andmost preferably adhesive tape connected to wire 199 is in the first 10cm of wire from sensor 182.

FIGS. 19A1 to 19D are schematic views of preferred geometry anddimensions of support structures 180 and sensing device 182. Specialgeometry and dimension of sensors and support structure is necessary forthe optimal functioning of the present invention. The dimensions anddesign for the support structure 180 are made in order to optimizefunction and in accordance with the geometry and dimensions of thedifferent parts of the tunnel.

FIG. 19A1 shows support structure 180 working as a patch. The patch 180contains sensor 182. The patch 180 may contain other hardware or solelythe sensor 182. Exemplary sensor 182 is a flat thermistor or surfacemount thermistor. The preferred longest dimension for the patch referredto as “z” is equal or less than 12 mm, preferably equal to or less than8 mm, and most preferably equal to or less than 5 mm. The shortestdistance from the outer edge of the sensor 182 to the outer edge of thepatch 180 is referred to as “x”. “x” is equal to or less than 11 mm,preferably equal to or less than 6 mm and most preferably equal to orless than 2.5 mm. For illustrative purposes the sensor 182 has unequalsides, and distance “y” corresponds to the longest distance from outeredge of the sensor to outer edge of the patch 180. Despite havingunequal sides, the shortest distance “x” is the determining factor forthe preferred embodiment. It is understood that the whole surface of thesensor 182 can be covered with an adhesive and thus there is no distancebetween the sensor and an outer edge of a support structure.

An exemplary embodiment for that includes a sensor in which the surfacetouching the skin at the BTT site is made with Mylar. The Mylar surface,which comprises the sensor itself, can have an adhesive in the surfacethat touches the skin. In this case, the support structure that caninclude a piece of glue or an adhesive may be constructed flush inrelation to the sensor itself. Accordingly in FIG. 19E support structure171 comprised of a piece of glue supports sensor 182 in position againstthe BTT area. Sensor 182 can include a Mylar, a thermistor, thermocoupleand the like, and the sensor 182 can be preferably at the edge of thesupport structure 171 such as a piece of glue or any support structure,and said sensor 182 can be preferably further insulated in its outersurface with a piece of insulating material 173, such as polyethylene.

As shown in FIG. 19A2, the sensor 182 has adhesive in its surface, to besecured to skin 11. The sensor then can be applied to the BTT site inaccordance with the principles of the invention. The preferred distance“x” equal to or less than 2.5 mm allows precise pinpoint placement ofsensor 182 at the main entry site of the tunnel and thus allows the mostoptimal signal acquisition, and it should be used for applications thatrequire greatest precision of measurements such as during monitoringsurgical procedures. Although a patch was used as support structure forthe description of the preferred dimensions, it is understood that thesame dimensions can be applied to any support structure in accordancewith the principle of the invention including clips, medial canthalpads, head mounted gear, and the like.

FIG. 19B is an exemplary embodiment of a round patch 180 with a flatsensor 182. Preferred dimensions “x” and “z” apply equally as for FIG.19A1. FIG. 19C is an exemplary embodiment of a patch 180 with abead-type sensor 182. Preferred dimensions “x” and “z” apply equally asfor FIG. 19A1. FIG. 19D is an exemplary embodiment of a supportstructure 180 with a sensor-chip 15. Sensor chip 15 comprises a sensorthat is integrated as part of a chip, such as an Application SpecificIntegrated Circuit (ASIC). For example sensor chip 15 includes sensor 15a, processor 15 b, and transmitter 15 c. Preferred dimension “x” applyequally as for FIG. 19A1. Other hardware such as power source 27 may behoused in the support structure 180 which can have a long dimensionreferred to as “d” that does not affect performance as long as thedimension “x” is preserved.

The support structure and sensor are adapted to match the geometry anddimensions of the tunnel, for either contact measurements or non-contactmeasurements, in which the sensor does not touch the skin at the BTTsite.

FIGS. 20A to 20C show the preferred dimensions “x” for any supportstructure in accordance with the present invention. The distance fromthe outer edge 180 a of the support structure to outer edges of sensor182 a is 11 mm, as shown in FIG. 20A. Preferably, the distance from theouter edge 180 a of support structure to outer edges of sensor 182 a is6 mm, as shown in FIG. 20B. Most preferably, the distance from the outeredge 180 a of the support structure to outer edges of sensor 182 a is2.5 mm, as shown in FIG. 20C.

Preferred positions of sensors 182 in relation to the medial corner ofthe eye 184 are shown in FIGS. 21A and 21B. Support structure 180positions sensor 182 lined up with medial corner 184 (FIG. 21B).Preferably, as shown in FIG. 21A, support structure 180 positions thesensor 182 above the medial corner 184.

The preferred embodiments of support structures incorporated as patchesand clips are preferably used in the hospital setting and in the healthcare field including continuous monitoring of fever or temperaturespikes. Support structures incorporated as medial canthal pads or headmounted gear are preferred for monitoring hyperthermia, hypothermia andhydration status of recreational athletes, professional athletes,military, firefighters, construction workers and other physicallyintensive occupations, occupational safety, and for preventing wrinkleformation due to thermal damage by sun light.

FIGS. 22A to 22C are perspective views of preferred embodiments showinga person 100 wearing support structures incorporated as a medial canthalpad 204 of eyeglasses 206. In a preferred embodiment shown in FIG. 22A,the medial canthal pad 204 contains sensor 202. Connecting arm 208connects medial canthal pad 204 to eyeglasses frame 206 next to regularnose pads 212. Sensor 202 is positioned on the superior aspect of themedial canthal area adjacent to the medial corner of the eye 210.

FIG. 22B is an exemplary preferred embodiment showing person 100 wearingsupport structure incorporated as medial canthal pads 204 with sensor202 integrated into specially constructed eyeglasses frame 216 andcontaining LEDs 228, 230. Connecting piece 220 which connects the leftlens rim 222 and right lens rim 224 is constructed and positioned at ahigher position than customary eyeglasses construction in relation tothe lens rim 222, 224. Due to the higher position of connecting piece220 and the special construction of frame 216, the upper edge 222 a ofleft lens rim 222 is positioned slightly above the eyebrow 226. Thisconstruction allows medial canthal pad 204 to be positioned at the BTTsite while LEDs 228,230 are lined up with the visual axis. Arm 232 ofmedial canthal pad 204 can be flexible and adjustable for properpositioning of sensor 202 on the skin at the BTT site and for movingaway from the BTT site when measurement is not required. The LED 228 isgreen and LED 230 is red, and said LEDs 228, 230 are activated when asignal reaches certain thresholds.

FIG. 22C is an exemplary preferred embodiment showing person 100 wearingsupport structure incorporated as medial canthal pads 204 with sensor202. Signal from sensor 202 is transmitted wirelessly from transmitter234 housed in the temple of eyeglasses 236. Receiving unit 238 receivesa signal from transmitter 234 for processing and displaying. Exemplaryreceiving units 238 include watch, cell phone, pagers, hand heldcomputers, and the like.

FIGS. 23A to 23B are perspective views of alternative embodimentsshowing support structures incorporated as a modified nose pad 242 ofeyeglasses 244. FIG. 23A is a perspective view showing eyeglasses 244containing a modified nose pad 242 with sensor 240 and processor 241,sweat sensor 246 and power source 248 supported by temple 250, andtransmitter 252 supported by temple 254, all of which are electricallyconnected. Modified nose pads 242 are comprised of oversized nose padswith a horn like extension 243 superiorly which positions sensor 240 ontop of the end of the tunnel.

FIG. 23B is a perspective view showing eyeglasses 256 containing anoversized modified nose pad 258 with sensor 240, sweat sensor 260supported by temple 262, and transmitter 264 supported by temple 266.Modified oversized nose pad 258 measures preferably 12 mm or more in itssuperior aspect 258 a and contains sensor 240 in its outer edge inaccordance with the dimensions and principles of the present invention.

Another preferred embodiment of the invention, shown in FIG. 24,provides goggles 268 supporting medial canthal pads 260 adapted toposition sensor 262, 264 at the tunnel site on the skin. As shown,goggles 268 also support transmitting device 261, power source 263,local reporting device 265 such as LED and an antenna 267 for remotereporting. Antenna 267 is preferably integrated as part of the lens rim269 of goggles 268.

As shown in FIG. 25, additional device related to the signal generatedby sensor 270 in medial canthal pad 272 include power switch 274, setswitch 276 which denotes a mode selector, transmitter 278 for wirelesstransmission of signals, a speaker 282, piezoelectric device 283, inputdevice 284 and processing device 286. The device 274, 276, 278, 282,284, and 286 are preferably supported by any portion of the frame ofeyeglasses 280. It is understood that a variety of devices, switches andcontrolling devices to allow storage of data, time and other multiplefunction switches can be incorporated in the apparatus in addition towires for wired transmission of signals.

FIG. 26A is a rear perspective view of one preferred embodiment showingsensors 299, 300 supported by medial canthal pads 290, 289 of eyeglasses292 and includes lens rim 297 and display 298 in addition to transmitter288, sweat sensor 294 and wires 296 disposed within temple 295 and lensrim 293 of said eyeglasses 292 and connected to display device 296.

FIG. 26B is a front perspective view of eyeglasses 292 including sweatsensor 294, transmitter 288 and wires 296 disposed within temple 295 andlens rim 293 of eyeglasses 292 and connected to a display device. Inthis embodiment sweat sensor 294 produces a signal indicating theconcentration of substances in sweat (e.g., sodium of 9 mmol/L) which isdisplayed on left side display 296 and sensor 300 supported by medialcanthal pad 290 produces a signal indicative of, for example, braintemperature of 98 degrees F. which is displayed on the right sidedisplay 298. Sweat sensor can be porous or microporous in order tooptimize fluid passage to sensors when measuring chemical components.

A variety of display devices and associated lenses for proper focusingcan be used including liquid crystal display, LEDs, fiber optic,micro-projection, plasma devices, and the like. It is understood that adisplay device can be attached directly to the lens or be an integralpart of the lens. It is also understood that a display device caninclude a separate portion contained in the lens rim or outside of thelens rim. Further, the two lenses and displays 296, 298 held within thelens rims 293, 297 can be replaced with a single unit which can beattached directly to the frame of eyeglasses 292 with or without the useof lens rim 293, 297.

FIG. 27 is a perspective view of another preferred embodiment showing athree piece support structure 304 and preferably providing a medialcanthal pad connecting piece 303 adapted as an interchangeableconnecting piece. This embodiment comprises three pieces. Piece 301comprises left lens rim 301 a and left temple 301 b. Piece 302 comprisesright lens rim 302 a and right temple 302 b. Piece 303 called the medialcanthal piece connector comprises the connecting bridge of eyeglasses303 a and the pad structure 303 b of eyeglasses. Pad piece 303 isparticularly adapted to provide medial canthal pads 306 for positioninga sensor 308 at the BTT site. In reference to this embodiment, the usercan buy three piece eyeglasses in accordance with the invention in whichthe connector 303 has no sensing capabilities, and it is thus a lowercost. However, the three piece eyeglasses 304 offers the versatility ofreplacing the non-sensing connector 303 by a connector 303 with sensingcapabilities. As shown in FIG. 27 connector 303 with medial canthal pads306 and sensor 308 includes also radio frequency transmitter 310 andcell 312. Therefore, connector 303 provides all the necessary hardwareincluding devices for sensing, transmitting, and reporting the signal.Any devices for attachment known in the art can be used includingpressure devices, sliding devices, pins, and the like.

Another preferred embodiment, as shown in FIG. 28A, provides a removablemedial canthal piece 314 supporting sensor 316. As shown, connectingbridge 320 of eyeglasses 318 are attached to medial canthal piece 314 ina releasable manner. Eyeglasses 318 further includes sweat sensor 322,324 supported by front part 311 and transmitting device 326 supported bytemple 313. Front part 311 of eyeglasses 318 defines a front browportion and extends across the forehead of the wearer and contains sweatsensor 322, 324. Sweat fluid goes through membranes in the sensor 322,324 and reaches an electrode with generation of current proportional tothe amount of analyte found in the sweat fluid.

FIG. 28B is a rear perspective view of the removable medial canthalpiece 314 showing visual reporting devices 323, 325 such as a green LEDand a red LED in left arm 328 and sensor 316 adapted to be positioned atthe end of the tunnel, and wire 326 for electrically connecting rightarm 329 and left arm 328 of medial canthal piece 314. FIG. 28C is afront perspective view of the removable medial canthal piece 314 showingpower source 330, transmitter 332 and sensor 316 in right arm 329 andwire 326 for electrically connecting right arm 329 and left arm 328 ofmedial canthal piece 314. Medial canthal piece 314 can be replaced by anon-sensing regular nose pad which would have the same size anddimension as medial canthal piece 314 for adequate fitting withconnecting bridge 320 of eyeglasses 318 of FIG. 28A. The removablemedial canthal piece can have, besides LED, a built-in LCD display fordisplaying a numerical value and/or RF transmitter. Therefore, theremovable medial canthal piece can have one or various reporting devicesintegrated as a single sensing and reporting unit.

FIG. 29 is a rear perspective view of one preferred embodiment of asupport structure incorporated as a clip-on 340 for eyeglasses andincludes attachment device 338 such as a hook or a magnet, transmittingdevice 342, processing device 344, power source 346, medial canthal pad348 mounted on a three axis rotatable structure 349 for properpositioning at the BTT site, and sensor 350. Clip-on 340 is adapted tobe mounted on regular eyeglasses and to fit the medial canthal pad 348above the regular nose pads of eyeglasses.

Sensing medial canthal pads can be preferably connected to attachmentstructure such as eyeglasses independent of the presence of specializedconnecting or attachment devices mounted in said eyeglasses such asgrooves, pins, and the like. This embodiment provides means for theuniversal use of sensing medial canthal pads in any type or brand ofattachment structure. FIG. 30 shows a front perspective view of medialcanthal pads 352 comprising an adhesive backing 354 for securing pad 352to an attachment structure such as eyeglasses or another supportstructure. Adhesive surface 354 is adapted to match an area ofeyeglasses that allow securing medial canthal pad 352 to saideyeglasses, such as for instance the area corresponding to regular nosepads of eyeglasses. Medial canthal pad 352 works as a completelyindependent unit and contains sensor 356, power source 358 and reportingdevice 360 electrically connected by wire 361,362. Reporting device 360includes local reporting with visual devices (e.g., LED), audio devices(e.g., piezoelectric, voice chip or speaker) and remote reporting withwireless transmission.

FIG. 31A is a top perspective view of one alternative embodiment of asupport structure incorporated as eyeglasses 380 with holes 364, 365 inregular nose pads 366, 376 for securing specialized medial canthal pads.Eyeglasses 380 includes wire 368 disposed within the right lens rim 371of the frame of eyeglasses 380 with said wire 368 connecting transmitter370 housed inside the right temple 369 to nose pad 366. Eyeglasses 380further includes wire 363 mounted on top of left lens rim 365 with saidwire 363 connecting transmitter 372 mounted on top of the left temple374 to nose pad 376. FIG. 31B is a magnified perspective view of part ofthe support structure 380 with hole 365 in regular nose pad 376. FIG.31C is a side perspective view of regular nose pad 366 with hole 364.FIG. 31D is a side perspective view of a medial canthal piece 382secured to hole 364 of regular nose pad 366.

FIG. 32A is a perspective view of a person 100 wearing a supportstructure comprised of medial canthal caps 390 secured on top of aregular nose pad 392 of eyeglasses 394. FIG. 32B is a perspective rearview of the medial canthal cap 390 showing sensor 396, transmitter chip398 and opening 397 for securing cap 390 to nose pads.

FIG. 33A is a perspective view of a medial canthal cap 390 being securedto the nose pad 392. Medial canthal cap 390 contains sensor 396,transmitter chip 398 and opening 397. FIG. 33B is a perspective viewshowing the end result of the medial canthal cap 390 secured to the nosepad 392.

Special nose pads are provided by the present invention for properpositioning a sensor at the BTT site. FIG. 34 is a perspective view of amodified left side rotatable nose pad 400 adapted to position a sensoron the skin at the end of the tunnel and includes nose pad 402 withsensor 401, arm 404, house 406 which houses a gear that allows rotationof a nose pad as a dial for positioning sensor 401 on different regionsof the tunnel identified as 1 and 2. Position 1 places the sensor inline with the medial canthal corner and reaches the general area of themain entry point of the tunnel and position 2 places the sensor abovethe medial canthal corner right at the main entry point of the tunnel.This embodiment allows automated activation of the sensing system andtakes advantage of the fact that the nose bridge is cold as seen in FIG.1 (nose is dark) and FIG. 2 (nose is purple and blue). When the pad isin its resting position (“zero”), the sensor 401 rests in a cold placewith temperature of 35.7° C. corresponding to the regular position ofnose pads on the nose. In position “zero” the sensor is in Sleep Mode(temperature of 35.8° C. or less). Changing the sensor to a hot regionsuch as the general area (position 1) or the main entry point (position2) automatically activates the sensor which goes into Active Mode andstart sensing function.

It is understood that numerous special nose pads and medial canthal padscan be used in accordance with the principles of the invention includinga pivotal hinge that allows pads to be foldable in total or in part,self-adjusting pads using a spring, pivoting, sliding in a groove, andthe like as well as self-adjusting mechanisms which are adaptable toanatomic variations found in different races. It is understood that themodified nose pads are preferably positioned high in the frame, mostpreferably by connecting to the upper part of the lens rim or within 6mm from the upper edge of the lens rim.

A variety of materials can be used including materials withsuper-adherent properties to allow intimate apposition of sensingdevices to the BTT site. A variety of metallic wires exhibitingsuper-elastic properties can be used as the hinge assembly mechanism forallowing proper positioning of a sensing device with the BTT site.Medial canthal pads can be made of a flexible synthetic resin materialsuch as a silicon rubber, conductive plastic, conductive elastomericmaterial, metal, pliable material, and the like so that appropriateapposition to the BTT site at the medial canthal area and properfunctioning is achieved. It is also understood that the medial canthalpads can exhibit elastic and moldable properties and include materialwhich when stressed is able to remain in the stressed shape upon removalof the stress. Any type of rubber, silicone, and the like with shapememory can also be used in the medial canthal pads and modified nosepad.

By greatly reducing or eliminating the interfering constituents andproviding a high signal to noise ratio with a sensor adapted to capturethermal radiation from the BTT, the present invention provides thedevices needed for accurate and precise measurement of biologicalparameters including chemical components in vivo using optical devicessuch as infrared spectroscopy. Moreover, the apparatus and methods ofthe present invention by enhancing the signal allows clinical usefulreadings to be obtained with various techniques and using differenttypes of electromagnetic radiation. Besides near-infrared spectroscopy,the present invention provides superior results and higher signal tonoise ratio when using other forms of electromagnetic radiation such asfor example mid-infrared radiation, radio wave impedance, photoacousticspectroscopy, Raman spectroscopy, visible spectroscopy, ultravioletspectroscopy, fluorescent spectroscopy, scattering spectroscopy andoptical rotation of polarized light as well as other techniques such asfluorescent (including Maillard reaction, light induced fluorescence andinduction of glucose fluorescence by ultraviolet light), calorimetric,refractive index, light reflection, thermal gradient, Attenuated TotalInternal Reflection, molecular imprinting, and the like. A sensoradapted to capture thermal energy at the BTE (Brain Thermal Energy)tunnel site provides optimal means for measurement of biologicalparameters using electromagnetic devices. The BTE tunnel is the physicalequivalent to the physiologic BTT and is used herein to characterize thephysics of the tunnel. The geometry and dimension on the skin surfaceare the same for the BTT and BTE tunnel.

The following characteristics of the BTE tunnel allow optimal signalacquisition. Skin at the end of the BTE tunnel is thin. With a thickskin radiation may fail to penetrate and reach the substance to bemeasured. Skin at the BTE tunnel is homogenous with constant thicknessalong its entire surface. Random thickness of skin as occurs in otherskin areas prevent achieving the precision needed. The BTE tunnel has nofat. The intensity of the reflected or transmitted signal can varydrastically from patient to patient depending on the individual physicalcharacteristics such as the amount of fat. A blood vessel in the end ofthe BTE is superficial, terminal and void of thermoregulatory shunts. Inother parts of the skin the deep blood vessels are located deep and varygreatly in position and depth from person to person. The BTE tunnel hasno light scattering elements covering its end such as bone, cartilageand the like. Thermal radiation does not have to go through cartilage orbone to reach the substance to be measured. The end of the BTE tunnel onthe skin has a special but fixed geometry and is well demarcated bypermanent anatomic landmarks. In other skin surfaces of the body,inconsistency in the location of the source and detector can be animportant source of error and variability.

Far-infrared radiation spectroscopy measures natural thermal emissionsafter said emissions interact and are absorbed by the substance beingmeasured. The present invention provides a thermally stable medium,insignificant number of interfering constituents, and a thin skin is theonly structure to be traversed by the thermal emissions from the BTEtunnel before reaching the detector. Thus there is high accuracy andprecision when converting the thermal energy emitted by the BTE tunnelinto concentration of the substance being measured.

The natural spectral emission by BTE tunnel changes according to thepresence and concentration of chemical substances. The far-infraredthermal radiation emitted follow Planck's Law and the predicted amountof thermal radiation can be calculated. Reference intensity iscalculated by measuring thermal energy absorption outside the substanceof interest band. The thermal energy absorption in the band of substanceof interest can be determined via spectroscopic means by comparing themeasured and predicted values at the BTE tunnel site. The signal is thenconverted to concentration of the substance measured according to theamount of thermal energy absorbed.

A sensor adapted to view the BTE tunnel provides means for measuring asubstance of interest using natural brain far-infrared emissions emittedat the BTE tunnel site and for applying Beer-Lambert's law in-vivo.Spectral radiation of infrared energy from the surface of the BTE tunnelsite corresponds to spectral information of chemical substances. Thesethermal emissions irradiated at 38 degrees Celsius can include the 4,000to 14,000 nm wavelength range. For example, glucose strongly absorbslight around the 9,400 nm band. When far-infrared thermal radiation isemitted at the BTE tunnel site, glucose will absorb part of theradiation corresponding to its band of absorption. Absorption of thethermal energy by glucose bands is related in a linear fashion to bloodglucose concentration in the thermally sealed and thermally stableenvironment present in the BTE tunnel.

The support structure includes at least one radiation source frominfrared to visible light which interacts with the substance beingmeasured at the BTE tunnel and a detector for collecting the resultingradiation.

The present invention provides method for measuring biologicalparameters comprising the steps of measuring infrared thermal radiationat the BTE tunnel site, producing output electrical signalsrepresentative of the intensity of the radiation, converting theresulting input, and sending the converted input to a processor. Theprocessor is adapted to provide the necessary analysis of the signal todetermine the concentration of the substance measured and for displayingthe results.

The present invention includes means for directing preferablynear-infrared energy into the surface of the skin at the end of the BTEtunnel, means for analyzing and converting the reflectance or backscattered spectrum into the concentration of the substance measured andsupport structure for positioning the light source and detector deviceadjacent to the surface of the skin at the BTE tunnel site.

The present invention also provides methods for determining theconcentration of a substance with said methods including the steps ofdirecting electromagnetic radiation such as near-infrared at the skin atthe BTE tunnel site, detecting the near-infrared energy radiated fromsaid skin at the BTE tunnel site, taking the resulting spectra andproviding an electrical signal upon detection, processing the signal andreporting concentration of the substance of interest according to saidsignal. The invention also includes device and methods for positioningthe light sources and detectors in stable position and with stablepressure and temperature in relation to the surface to which radiationis directed to and received from.

The present invention further includes devices for directing infraredenergy through the nose using medial canthal pads, devices forpositioning radiation source and detector diametrically opposed to eachother, and devices for analyzing and converting the transmittedresulting spectrum into the concentration of the substance measured. Thepresent invention also provides methods for measuring biologicalparameters with said methods including the steps of directingelectromagnetic radiation such as near-infrared through the nose usingmedial canthal pads, collecting the near-infrared energy radiated fromsaid nose, taking the resulting spectra and providing an electricalsignal upon detection, processing the signal and reporting concentrationof the substance measured according to said signal. The invention alsoincludes means and methods for positioning the radiation sources anddetectors in a stable position and with stable pressure and temperaturein relation to the surface to which radiation is directed through.

The present invention yet includes devices for collecting naturalfar-infrared thermal radiation from the BTE tunnel, devices forpositioning a radiation collector to receive said radiation, and devicesfor converting the collected radiation from the BTE tunnel into theconcentration of the substance measured. The present invention alsoprovides methods for measuring biological parameters with said methodsincluding the steps of using the natural far-infrared thermal emissionfrom the BTE tunnel as the resulting radiation for measuring thesubstance of interest, collecting the resulting radiation spectra,providing an electrical signal upon detection, processing the signal andreporting the concentration of the substance measured according to saidsignal.

A drug dispensing system including an infusion pump can be activatedaccording to the level of the substance measured at the BTE tunnel, forexample insulin can be injected automatically as needed to normalizeglucose levels as an artificial pancreas.

Any substance present in blood which is capable of being analyzed byelectromagnetic devices can be measured at the BTE tunnel. For examplebut not by way of limitation such substances can include exogenouschemicals such as drugs and alcohol as well as endogenous chemicals suchas glucose, oxygen, lactic acid, cholesterol, bicarbonate, hormones,glutamate, urea, fatty acids, triglycerides, proteins, creatinine,aminoacids and the like. Values such as pH can also be calculated as pHcan be related to light absorption using reflectance spectroscopy.

In accordance with FIG. 35 a schematic view of one preferred reflectancemeasuring apparatus of the present invention is shown. FIG. 35 shows alight source 420 such as an infrared LED and a photodetector 422 locatedside-by-side and disposed within support structure 426 such as a medialcanthal pad or modified nose pads of eyeglasses directing radiation 424at the BTE tunnel 430 with said light source 420 laying in apposition tothe skin 428 at the BTE tunnel 430. The light source 420 delivers theradiation 424 to the skin 428 at the BTE tunnel which is partiallyabsorbed according to the interaction with the substance 432 beingmeasured resulting in attenuated radiation 425. Part of the radiation424 is then absorbed by the substance 432 and the resulting radiation425 emitted from BTE tunnel 430 is collected by the photodetector 422and converted by a processor into the blood concentration of thesubstance 432. Thin skin 428 is the only tissue interposed betweenradiation 424, 425 and the substance 432 being measured. Theconcentration of the substance 432 is accomplished by detecting themagnitude of light attenuation collected which is caused by theabsorption signature of the substance being measured.

Infrared LEDs (wavelength-specific LEDs) are the preferred light sourcefor this embodiment because they can emit light of known intensity andwavelength, are very small in size, low-cost, and the light can beprecisely delivered to the site. The light source 420 emits preferablyat least one near-infrared wavelength, but alternatively a plurality ofdifferent wavelengths can be used. The light source emits radiation 424,preferably between 750 and 3000 nm, including a wavelength typical ofthe absorption spectrum for the substance 432 being measured. Thepreferred photodetector includes a semiconductor photodiode with a 400micron diameter photosensitive area coupled to an amplifier as anintegrated circuit.

FIG. 36 shows a schematic view of a person 100 wearing a supportstructure 434 and light source 436 and detector 438 adapted to measurebiological parameters using spectral transmission device. The lightsource 436 and photodetector 438 are positioned diametrically opposed toeach other so that the output of the radiation source 436 goes throughthe nasal interface 442 containing the substance 440 being measuredbefore being received by the detector 438. Photodetector 438 collectsthe resulting transmitted radiation which was directed through the nasalinterface 442. A variety of LEDs and optical fibers disposed within thesupport structure 434 such as the medial canthal pads, nose pads andframes of eyeglasses are preferably used as a light delivery for thelight source 436 and the light detector 438.

Arms of support structures 434 such as medial canthal pads are moveableand can be adjusted into different positions for creating a fixed orchangeable optical path. Preferred substances measured include oxygenand glucose. The brain maintains constant blood flow, whereas flow inextremities change according to cardiac output and ambient conditions.The oxygen levels found in the physiologic tunnel reflects centraloxygenation. The oxygen monitoring in a physiologic tunnel isrepresentative of the general hemodynamic state of the body. Manycritical conditions such as sepsis (disseminated infection) or heartproblems which alter perfusion in most of the body can be monitored.Oxygen in the BTE tunnel can continuously monitor perfusion and detectearly hemodynamic changes.

FIG. 37 is a schematic cross-sectional view of another preferredembodiment of the present invention using thermal emission from the BTEtunnel. FIG. 37 shows a support structure 450 housing a thermal infrareddetector 444 which has a filter 446 and a sensing element 448 with saidsensing element 448 being preferably a thermopile and responding tothermal infrared radiation 452 naturally emitted by the BTE tunnel 454.The support structure 450 is adapted to have sensing device 448 with afield of view that corresponds to the geometry and dimension of the skin462 at the end of the BTE tunnel 454. Support structure 450 provideswalls 456, 458 which are in contact with the skin 462 with said wallscreating a cavity 460 which contains thermal radiation 453 which hasalready passed through thin skin 462.

For example in the thermally sealed and thermally stable environment inthe BTE tunnel 454, at 38° Celsius spectral radiation 453 emitted as9,400 nm band is absorbed by glucose in a linear fashion according tothe amount of the concentration of glucose due to thecarbon-oxygen-carbon bond in the pyrane ring present in the glucosemolecule. The resulting radiation 453 is the thermal emission 452 minusthe absorbed radiation by the substance 464. The resulting radiation 453enters the infrared detector 444 which generates an electrical signalcorresponding to the spectral characteristic and intensity of saidresulting radiation 453. The resulting radiation 453 is then convertedinto the concentration of the substance 464 according to the amount ofthermal energy absorbed in relation to the reference intensityabsorption outside the substance 464 band.

The same principles disclosed in the present invention can be used fornear-infrared transmission measurements as well as for continuous wavetissue oximeters, evaluation of hematocrit, blood cells and other bloodcomponents. The substance measured can be endogenous such as glucose orexogenous such as alcohol and drugs including photosensitizing drugs.

Numerous support structures can position sensors at the BTT site formeasuring biological parameters. Accordingly, FIG. 38 is a sideperspective view of an alternative embodiment showing a person 100 usinghead mounted gear 470 as a support structure positioning with wires 478and sensor 476 on the skin at the BTT site. A microelectronic package472 containing transmitting means, processing means, and power source isdisposed within or mounted on headband 470, with said headband 470providing wire 478 from microelectronic package 472 for connection withsensing device 476 on the skin at the BTT site.

It is understood that the sensing device can be an integral part of thesupport structure or be connected to any support structures such asusing conventional fasteners including screw, pins, a clip, atongue-groove relationship, interlocking pieces, direct attachment,adhesives, mechanical joining, and the like; and said support structuresinclude patches, clips, eyeglasses, head mounted gear, and the like.

Various means to provide electrical energy to the sensing system weredisclosed. The BTE tunnel offers yet a new way for natural generation ofelectrical energy. Accordingly, FIG. 39 is a schematic diagram of apreferred embodiment for generating thermoelectric energy from the BTEtunnel to power the sensing system. The generator of the inventionconverts heat from the tunnel into electricity needed to power thesystem. A thermoelectric module is integrated into the support structureto power the sensing system. The thermoelectric module preferablyincludes a thermopile or a thermocouple which comprises dissimilarmetallic wires forming a junction. As heat moves from the tunnel throughthe thermoelectric module an electric current is generated. Since theBTE tunnel is surrounded by cold regions, the Seebeck effect can providemeans for generating power by inducing electromotive force (emf) in thepresence of a temperature gradient due to distribution of electriccharges at the surface and interface of the thermoelectric circuitgenerated by the temperature at the BTE tunnel.

Accordingly, FIG. 39 shows the junctions T1 and T2 of metallic wire A470 and metallic wire B 472 kept at different temperatures by placingjunction T1 at the main entry point of the tunnel and junction T2 in acold area such as the nose bridge (denoted in blue or purple in FIG. 1B,and referred herein as blue-purple nose). Metallic wires A 470 and B 472are made of different materials and electric current flows from the hotto the cold region due to the thermal gradient with a magnitude given bythe ratio of the thermoelectric potential. The potential U is given byU=(Q_(a)−Q_(b))*(T₁−T₂), where Q_(a) and Q_(b) denote the Seebeckcoefficient (thermoelectric power) of metal A and metal B₂ and T₁denotes temperature at the entry point of the BTE tunnel and T₂ denotestemperature at the blue-purple nose. The thermoelectric potentialgenerated can power the sensing system and a capacitor 474 inserted intothe system can be used to collect and store the energy and MCU 476 isadapted to control the delivery of energy as needed for measuring,processing and transmitting the signal.

It is understood that other means to convert thermal energy from the BTEtunnel into electricity can be used. It is also understood that thesurface of the eye and caruncle in the eye can provide a thermalgradient and Seebeck effect, however it is much less desirable thanusing the skin at the end of the BTE tunnel since hardware and wirestouching the surface of the eye and/or coming out of the eye can bequite uncomfortable and cause infection. It is yet understood that thecold end can include any relatively cold article including the frame ofthe glasses as well as the air.

Contrary to that numerous support structures disclosed in the presentinvention including eyeglasses can easily be adapted to provide in anunobtrusive manner the power generating system of the invention, forexample by using a support structure such as eyeglasses for positioningthe hot junction at the BTE site using medial canthal pads andpositioning the cold junction on the nose using regular nose pads ofeyeglasses. It is also understood that although the power generatingsystem using Brain Thermal Energy was designed for powering the sensingsystem of the present invention, any other electrical device could beadapted to be supplied with energy derived from the Brain Thermal Energytunnel.

Additional embodiments include support structures to position the sensorat the BTT site of animals. Many useful applications can be achieved,including enhancing artificial insemination for mammalian species bydetecting moment of ovulation, monitoring herd health by continuousmonitoring of brain temperature, detection of parturition and the like.

Accordingly, FIG. 40 is a perspective view of a preferred embodimentshowing an animal 101 with sensor 480 positioned at the BTT site withwire 482 connecting sensor 480 with a microelectronic package 484containing a transmitting device, a processing device, and power sourcein the eyelid pocket 486 of animal 101. Signal from microelectronicpackage 484 is preferably transmitted as radio waves 489. The signalfrom the transmitter in package 484 can be conveyed to a GPS collarallowing the identification of the animal having a high temperatureassociated with the localization of said animal by GPS means. Wheneverthere is an increase in brain temperature identified by the sensingdevice 480, the signal of high temperature activates the GPS collar toprovide the localization of the affected animal. Alternatively theremote radio station receiving waves 489 activate the GPS system whenthe abnormal signal is received. In this case, the transmitter inpackage 484 only sends the signal to the remote station, but not to theGPS collar.

FIG. 41A is a perspective view of a portable support structure 490positioning sensor 492 in contact with the skin 494 at the BTT site formeasuring biological parameters. Support structure 490 incorporated as athermometer with a contact sensor 492 is held by a second person 17 forpositioning the sensor 492 on the skin 494 and performing themeasurement. FIG. 41B is a perspective view of a portable supportstructure 496 with walls 500 positioning non-contact sensor 498 such asa thermopile with a field of view that matches in total or in part thegeometry and dimension of the skin area at the end of the BTT. Supportstructure 496 incorporated as an infrared thermometer is held by asecond person 105 for positioning the sensor 498 and measuringbiological parameters. Although it is understood that pointing aninfrared detector to the BTT site can be used in accordance with theinvention, the temperature measured is not as clinically useful becauseof the ambient temperature. Therefore, the support structure 496contains walls 500 that create a confined environment for thermalradiation to reach sensor 498 from the skin over the tunnel. Walls 500of the support structure are adapted to match the geometry of the tunneland to provide a cavity 499 with the boundaries consisting of the sensorsurface 492 and the skin area 493 viewed by said sensor 498, in asimilar manner as described for FIG. 37.

Now, with reference to FIGS. 42A and 42B, FIG. 42A is a schematicdiagram showing the support structure 496, also referred to herein as ahousing, a window 502 and radiation sensor 504 contained in the housing496 and an extension 510 secured to the housing adapted for temperaturemeasurement at the BTT area. In a preferred embodiment, the extension510 has walls 500 and is substantially conical in shape and secured to ahousing 496 adapted to be held by a hand 105 as shown in FIG. 41B. Tomeasure the temperature, a user 105 positions the extension 510 adjacentto the BTT site such that the walls 500 of the extension 510 lie on theskin at the BTT area and the radiation sensor 504 views the BTT area.FIG. 42B is a schematic view showing the walls 500 of extension 510creating a cavity 499 wherein thermal radiation 506 emitted from theskin 508 at the BTT area 518 is received by the radiation sensor 504.BTT area 506 is surrounded by the thick skin and fat in non-BTT areas512. BTT temperature measurements are obtained from the output of theradiation sensor 504 contained in the housing 496. Electronics 514within the housing 496 convert the received radiation to a temperaturelevel which is displayed on a housing display 516 as illustrativelyshown in FIG. 41B.

The radiation sensor 504 views at least a portion of the BTT surfaceskin area 508 through an infrared radiation transparent window 502 anddetect infrared radiation 506 from the BTT skin surface 508. Theradiation sensor 504 is preferably a thermopile, but other radiationsensors may also be used such as pyroelectric detectors or any otherradiation sensors that detect heat flux from the surface beingevaluated. Exemplary window 502 materials include silicon and germanium.The sensor 504 is preferably mounted in an extension 510 which is shapedto match the dimension and geometry of the BTT area 508. The extension510 can easily be positioned such that only the skin area 508 at the endof the BTT 518 may be viewed by the radiation sensor 504 wherein theskin area 508 is at substantially the same temperature as the braintemperature. Once in a position for the sensor 504 to view the BTT skinarea 508, a button 522 is pressed to begin a measurement and theprocessing 514 within the housing 496 determines the brain temperatureand display the value in a liquid crystal display 516 coupled to a sounddevice 524 for emitting an audio signal. A disposable cover may be usedto cover any part of the apparatus in contact with the skin.

Although the temperature at the end of the BTT is substantiallyequivalent to the brain temperature based on the temperature of thecavernous sinus and cerebral blood, a variety of mathematicalcalculations and means can be used to determine the temperature at theBTT area including arterial heat balance, venous heat balance, andambient temperature. It is understood that the BTT detector can containa sensor for measuring ambient temperature and said measured ambienttemperature be used for calculating temperature of the subject.

The temperature at the BTT area can be used as a reference for adjustingmeasurement acquired in other parts of the body outside the BTT area.The electrical equivalent of the BTT tunnel is an area of high voltagebut low current, in which the voltage representing the temperature isvirtually equal at the two ends of the tunnel. The high perfusion in theend of the BTT keeps a high temperature at the skin at the end of saidend of the BTT.

The present invention also provides a method for detecting bodytemperature including the steps of providing a temperature detectorpositioned adjacent to the BTT during temperature detection anddetermining the temperature based on the radiation sensed at the BTTarea. It is understood that the detector can remain in one position ormove around the BTT area to identify the surface with the highesttemperature.

A further method of detecting body temperature includes the steps ofscanning a temperature detector across the BTT area and other areas inthe head or in the contra-lateral BTT area and selecting the highesttemperature, preferably selecting the highest temperature by scanningthe right and the left BTT areas with the processor in the BTT detectordetermining and selecting the highest temperature.

Another method for identifying the highest temperature point in the BTTarea can be found by scanning a radiation detector over the BTT area andhaving a processor adapted to select the highest reading and indicatethat with an audio signal. The temperature detector 20 provides anaudible beep with each peak reading.

FIG. 43A to 43C are diagrams showing preferred embodiments for thediameter of the cone extension 510 at the end of the housing 496 incontact with the skin 508 at the BTT site 518. It is understood thatalthough any shape can be used for the extension, the extension takespreferably the form of a cone with a radiation sensor positioned to viewthe BTT area. The cup 520 has an outer diameter at its end which isequal to or less than the BTT area. In FIG. 43A, for the radiationsensor 504 viewing the general area of the BTT site 508 the preferredouter diameter of the end 524 of the cup 520 is equal to or less than 13mm. In FIG. 43B for the radiation sensor 504 viewing the general mainentry point of the BTT site 508 the preferred outer diameter of the end524 of the cup is equal to or less than 8 mm. In FIG. 43C, for theradiation sensor 504 viewing the main entry point the preferred outerdiameter of the end 524 of the cup 520 is equal to or less than 5 mm. Itis understood that although the preferred geometry of the radiationsensor and extension is round and has a substantially conical shape, anyother shape of the radiation sensor and/or extension can be usedincluding oval, square, rectangular, and the like. It is understood thatthe diameter and geometry is preferably chosen to match the geometry ofthe BTT area. It is also understood that the dimension of the sensor 504is adapted to match the dimension of the cup 520 to the viewing area ofthe skin 508.

In accordance with a further aspect of the present invention, theextension is adapted to fit on top of the eyelids. The portion of theextension 510 of the housing 496 in contact with the skin 508 can alsohave an inner concave surface that matches the eyelid contour.Alternatively, the portion of the conical extension 510 in contact withthe skin 508 can have a convex surface to match the medial canthal areaand upper lid above the medial corner of the eye.

It is also understood that the dimensions for pediatric use are abouttwo thirds of the dimension for adult size, or even half or less thanhalf of adult size especially in small children. Accordingly, thepreferred sizes of the outer diameter of the extension for children are:for the radiation sensor viewing the general area the preferred outerdiameter of the extension is equal to or less than 9 mm for viewing thegeneral area of the BTT, equal to or less than 6 mm for viewing thegeneral main entry point of the BTT, and equal to or less than 4 mm forviewing the main entry point of the BTT.

Besides the preferred round shape for the end 524 of extension 510,FIGS. 44A and 44B shows alternative geometries and shapes of end 524extension 510 for non-contact sensor with said sensor viewing at least aportion of the BTT area next to the corner 528 of the eye 526. In FIG.44A, the outer shape of the end 524 of extension 510 is shown as an ovalshape. FIG. 44B shows an elliptical, banana or half moon shape of end524 of extension 510 for viewing the medial canthal area and the uppereye lid area.

FIGS. 45A and 45B shows exemplary geometries and shapes for a supportstructure containing a contact sensor with said sensor positioned on theskin at the BTT area. FIG. 45 is a schematic frontal view showing atemperature sensor 530 in the shape of a rod contained in a patch 532and positioned vertically on the BTT area 534 next to the corner of theeye 538 and nose 537 with a cord 536 extending from the distal end ofthe sensor 530. FIG. 45B is a side view of FIG. 45A showing sensor 530with cord 536 contained in patch 532 next to the eye 539. A sensor isplaced centrally in the patch, wherein the patch measures less than 11mm in diameter.

FIGS. 46A to 46D shows exemplary geometries and shapes for medialcanthal pads or modified nose pads and their relation to the medialcorner of the eye. FIG. 46A, shows a frontal view of a modified nose pad540 containing a sensor 542 located centrally in said nose pad 540wherein the sensor 542 is positioned on the skin at the BTT area next tothe corner of the eye 544 and nose 546. FIG. 46B is a side view showingthe eye 545 and nose 546 and the modified nose pad 540 with the sensor542 positioned at the BTT site. FIG. 46C show a frontal view of amodified nose pad 550 having a sensor 552 located in its outer edge andpositioned on the skin area at the BTT site next to the corner of theeye 554 and nose 556. FIG. 46D is a side view showing the eye 555 andnose 556 and the modified nose pad 550 with the sensor 552 positioned atthe BTT site. It is understood that although an extension is thepreferred embodiment with the sensor not contacting the skin, aninfrared sensor probe adapted to touch the skin at the BTT area can alsobe used.

Now in reference to the thermal imaging systems of the presentinvention, FIG. 47 is a schematic block diagram showing a preferredembodiment of the infrared imaging system of the present invention. FIG.47 shows a BTT ThermoScan 560 comprising a camera 562, a microprocessor564, a display 566, and a power source 568. The system further includesproprietary software and software customized for the precise measurementand mapping of the BTT area. The BTT ThermoScan 560 includes a camera562 with a lens 574, an optical system 572 that can contain mirrors,filters and lenses for optimizing image acquisition, and a photodetector570, also referred to herein as a radiation sensor or a radiationdetector, to quantify and record the energy flux in the far infraredrange. The display unit 566 displays the thermal image of the BTT beingviewed by the lens 574 in the camera. Radiation detector materials knownin the art can be used in the photodetector 570 including alloys ofindium-antimonide, mercury-cadmium-telluride, Copper doped Germanium,Platinum Silicide, Barium Strontium Titanate, and the like.

The infrared radiation detector converts the incident radiation thatincludes the BTT area into electrical energy which is amplified. Thedetector 570 is responsive to infrared radiation to provide an outputsignal and discrete points related to the intensity of the thermalenergy received from the BTT area and the surrounding area around theBTT area.

The discrete points are imaged and each point source must have enoughenergy to excite the radiation detector material to release electrons.Any point size can be used, but preferably with a size between 1 and 2mm in diameter. When using an angle of 1.3 mrads, the BTT ThermoScan cancapture an instantaneous image from a point size of approximately 1 mmdiameter at a distance of 1 m from the detector. It is understood thatany spatial resolution for optimal capturing of the BTT image can beused, but it is preferably between 1.0 and 1.6 mrad. The camera 562 ofthe BTT ThermoScan 560 has a field of view adapted to view the BTT area.Discrete points are further converted into an image of the face thatincludes the BTT area in the medial corner of the eye and upper eyelid.The screening function of the BTT ThermoScan is based on the temperatureat the BTT area, either absolute temperature or the differentialtemperature of the BTT area in relation to a reference.

The electrical response to the thermal radiation can be displayed on themonitor as intensity, with a strong signal producing a bright (white)point as seen in FIG. 1A with said white point being representative ofthe highest radiant energy from the source. In FIG. 1A the source is thehuman face and the highest intensity of radiation is found in the BTTarea. Calibration of the display screen result in a continuum shades ofgray, from black (0 isotherm) to bright white (1 isotherm). Each pointis digitally stored for further processing and analysis.

It is understood that a variety of lenses, prisms, filters, Fresnellenses, and the like known in the art can be used to change the angle ofview or optimize signal acquisition and capture of thermal energy fluxfrom the face and the BTT area. The lens of the BTT ThermoScan 560 ispreferably perpendicular to the plane of the human face or of the BTTarea being viewed.

The radiation detector material in the BTT ThermoScan 560 is preferablysensitive to radiation with wavelength ranging from 8 to 12 μm. The BTTThermoScan 560 has a temperature span set between 2 to 5 degrees Celsiusand is extremely sensitive and adapted to discern temperatures to within0.008 degrees Celsius to 0.02 at a range of 1 meter. Temperaturemeasurements can be based on radiometric means with built-in electronicsor by differential using a reference such as a black body. Although thesystem can be uncooled, to maximize the efficiency of the detector andachieve an optimum signal to noise ratio the detector can be cooledusing solid state means, liquid nitrogen, evaporation of compressedargon gas, piezoelectric components, and the like.

Many radiation detectors capable of detecting infrared waves are beingdeveloped including silicon based, solid state systems, andmicrobolometers, and all said systems new or to be developed in thefuture can be used in the apparatus of the present invention to detectthermal radiation from the BTT with the display of a corresponding imageof the BTT in a monitor.

An exemplary infrared detector system includes a microbolometer which isfabricated on silicon substrates or integrated circuits containingtemperature sensitive resistive material that absorbs infraredradiation, such as vanadium oxide. The incident infrared radiation fromthe BTT area is absorbed by the microbolometer producing a correspondingchange in the resistance and temperature. Each microbolometer functionsas a pixel and the changes in electrical resistance generate anelectrical signal corresponding to thermal radiation from the BTT areathat can be displayed in a screen of a computer.

The display of the image of the BTT is the preferred embodiment of theinvention, but the present invention can be implemented without displayof an image. Radiation coming from the BTT can be acquired by theradiation sensors aforementioned and the temperature of the BTT area canbe calculated based on the electrical signal generated by the radiationsensor using a reference. Any means to detect thermal radiation and/ortemperature from the BTT area can be used in accordance with theprinciples of the invention.

Besides the easy manipulation of temperature at the skin level outsidethe BTT area, significantly lower temperatures are found in the areasoutside the BTT as shown in the image on the screen, and depicted in thephotos of FIGS. 1A and 1B. The lower and more unstable temperatureoutside the BTT area results in generating a non-clinically significanttemperature level or thermal image when said areas outside the BTT areused for sensing thermal radiation and/or measuring temperature.

It is understood that a variety of signal conditioning and processingcan be used to match the temperature areas outside the BTT area to avalue that corresponds to the BTT area, and those methods also fall inthe scope of the invention. Image outside the BTT area as seen more likea blur compared to the BTT area and superimposition of images thatinclude the BTT area can also be used for achieving higher level ofaccuracy during temperature measurements. Comparing a radiation patternoutside the BTT area with the BTT area without necessarily creating animage of the BTT area can also be used for accurate and precisetemperature measurement and evaluation of the thermal status of the bodyin accordance with the principles of the invention. Any method or deviceused for temperature evaluation or evaluation of the thermal status thatis based on the temperature level or thermal radiation present in theBTT area by generating or not generating an image falls within the scopeof the present invention.

FIG. 48 is a schematic view showing the thermal imaging system 560 ofthe present invention adapted to be used in an airport 580 including aninfrared camera 582, a processor 584, and a display 586 which aremounted in a support structure 588 at an airport 580. Camera 582 scansthe BTT area present in the medial corner of the eye 590 in a human face591 and provides an output signal to a signal processor 584. The outputsignal is an electronic signal which is related to the characteristic ofthe thermal infrared energy of the BTT 590 in the human face 591 whenpeople 592, 593 walking by look at or are viewed by the camera 582. Theprocessor 584 processes the output signal so that an image of the BTTarea 594 can be formed by the display 586 such as a computer monitor.

Exemplarily, passenger 592 is looking at the camera 582 for sensing thethermal radiation from the BTT area 590, with said passenger 582 holdinghis/her eyeglasses since for the camera 582 to precisely view the BTTarea 590 the eyeglasses have to be removed. If someone goes by thecamera 582 without a thermal image of the BTT 590 being acquired analarm will be activated. Likewise, if someone has a temperaturedisturbance an alert indicative of said temperature disturbance isactivated.

FIG. 49 is a schematic view showing the thermal imaging system 560 ofthe present invention adapted to be used in any facility that has agathering of people such as a movie theater, a convention, stadium, aconcert, a trade show, schools, and the like. In FIG. 49 the infraredcamera 596 of the BTT Thermoscan 560 is located at the entrance of theaforementioned facilities and while people 598 show their identificationor ticket to an agent 602, the BTT ThermoScan 560 scans the side of theface of the people 598 to capture a thermal image 600 and temperature atthe BTT tunnel which is displayed in a remote computer display 604. Thecamera 596 has adjustable height and a tracking system to track theheat, and therefore said camera 596 can position itself for sensingthermal radiation from people 598 at different distances and ofdifferent height. It is also understood that the BTT Thermoscan 560 canbe used in any facility including optical stores for adjustingpositioning of sensors in eyeglasses.

A facility that is of strategic importance such as a governmentbuilding, military bases, courts, certain factories and the like canalso benefit from screening for temperature disturbances. As shown inFIG. 50, a guard 606 is standing by an infrared detector camera 608 forsensing thermal radiation from the BTT area and preferably including acard slot 610 in its housing 612. Although a guard 606 is shown, the BTTThermoScan of the present invention can work in an unguarded entrance.In this embodiment the BTT thermal image 560 works as a key toautomatically open a door 614. Accordingly, employee 616 scan herCompany Identification card in the slot 610 which then prompts the userto look at the camera 608 for capturing the thermal image of the BTTarea. If the temperature of the BTT is within acceptable limits, theprocessor of the ThermoScan 608 is adapted to open the door 614. If theBTT temperature shows fever indicating a possible infection the employeeis directed to a nurse. This will greatly help safety procedures infacilities dealing with food products in which one employee having acontagious disease can contaminate the whole lot of food products.

FIG. 51 is a schematic view of another embodiment of the presentinvention to monitor temperature disturbances during physical activitysuch as sports events, military training, and the like, showing infraredthermal detector 620 sensing thermal radiation 622 from an athlete 624.The infrared thermal detector 620 includes a detector head 626 whichcontains an infrared sensor 628, a digital camera, 630 and a set oflights, red 632, yellow 634 and green 636 indicating the thermal statusof the athlete with the red light 632 indicating temperature that canreduce safety or performance of the athlete, a red light 632 flashingthat indicates temperature outside safe levels, a yellow light 634indicating borderline temperature, a green light 636 indicating safetemperature levels, and a green light 636 flashing indicating optimumthermal status for enhancing performance. The infrared sensor 628detects the thermal radiation 622 and if the red light 632 is activatedthe digital camera 626 takes a picture of the scene to identify thenumber of the athlete at risk for heatstroke or heat illness. Theinfrared detector 620 further includes a processor 638 to process and atransmitter 640 to transmit the signal wired or wirelessly. It isunderstood that a wider field of view can be implemented with multipleBTT signals being acquired simultaneously as shown by BTT radiation froma second athlete 642 being sensed by the infrared detector head 626.

Now referring to FIG. 52A, the BTT ThermoScan of this embodimentpreferably includes a micro solid state infrared detector 650 which ismounted on a visor 652 of a vehicle 654 for sensing thermal radiationfrom the BTT of a driver 656 and of ambient radiation monitored byprocessor 658 mounted in the dashboard of the vehicle to determinewhether the driver 656 is at risk of temperature disturbance(hyperthermia or hypothermia) which hampers mental and physical functionand can lead to accidents. In addition the temperature at the BTT siteof the driver 656 can be used for automated climate control and seattemperature control of vehicle 654. When the image of the BTT siteindicates high body temperature the air conditioner is automaticallyactivated.

FIG. 52B is a representation of an image generated by the detector 650showing the BTT area 660 on a display 662. FIG. 48 is a representationof an illustrative image generated with the infrared imaging system ofthe present invention. FIG. 52B shows a frontal view of the human faceand the BTT area 660 displayed on a screen 662 as well as the otherareas outside the BTT area present in the human face such as forehead664, nose 666, and cheeks 668. Please note that FIG. 1B shows an actualphoto of the geometry of the general entry point of the BTT displayed ona screen and FIG. 4A shows a side view of the human face and of the BTTarea displayed on a screen.

FIG. 53 shows an illustrative method of the present inventionrepresented in a flowchart. It is to be understood that the method maybe accomplished using various signal processing and conditioning withvarious hardware, firmware, and software configurations, so the stepsdescribed herein are by way of illustration only, and not to limit thescope of the invention. The preferred embodiment includes detectingthermal radiation from a source that includes at least a portion of theBTT area (step 670). At step 672 an image from a radiation source thatincludes at least a portion of the BTT area is generated. At step 674the image generated at step 672 is displayed. Step 676 identifiestemperature levels from the image displayed at step 674. Step 678determines whether the temperature identified at step 676 matches atemperature target. The temperature target can be indicative of atemperature disturbance or indicative of the need to change the climatecontrol level of the vehicle. Considering a temperature disturbance, ifyes and there is a match between the detected temperature at the BTT andthe stored target temperature, then an alarm is activated at step 680informing the subject of the temperature disturbance (e.g., fever,hyperthermia, and hypothermia) and processing continues at step 670. Ifthere is no match, step 678 proceeds to the next operation at step 670.

To enhance the image generated by the BTT ThermoScan, the method furtherincludes aligning the BTT area with the field of view of the infrareddetector and by removing eyeglasses during thermal detection of the BTTarea.

FIG. 54A is a perspective view of another preferred embodiment showing aperson 100 wearing a support structure 680 comprised of a patch withsensor 682 positioned on the skin at the end of the tunnel and connectedby a wire 684 to a helmet 686 which contains the decoding and processinghardware 688, transmitter 702 and display unit 704. Exemplary helmetsinclude ones known in the art for the practice of sports, military,firefighters, and the like. Alternatively, as shown in FIG. 54B thesupport structure includes eyewear 700 with a warning light 702 andsensor 710 of eyewear 700 connected by wire 704 to the head mountedgear, such as a helmet 706. Sensor 710 has an arm 708 with a springmechanism 709 for positioning and pressing the sensor 710 against theskin at the BTT area.

Now in reference to FIG. 55, the temperature sensor 710 can be mountedon nose pieces 712 of masks 714, for example a mask for firefighters.Wire 716 from mask 714 is mounted in an insulated manner, such as beingpositioned within the structure of mask 714 and air tube 718 thatconnects mask 714 to air pack 722. Wire 716 connects sensor 710 to radiotransmitter 720 located in the air pack 722. Alternatively, wire 716 canbe mounted external to the air tube 718. A warning light 724 in the mask714 alerts the firefighter about high or low temperature.

FIG. 56A is a diagram showing a BTT entry point detection system, whichcorresponds to the area with the highest temperature in the surface ofthe body, including temperature sensor 730, amplifier 732, processor734, and pager 736. Processor 734 is adapted to drive the pager 736 toemit a high frequency tone for a high temperature and a low frequencytone for a low temperature. Scanning of the BTT area with the sensor 730allows precise localization of the main entry point of the BTT, whichcorresponds to the highest frequency tone generated during the scanning.Another preferred embodiment for detection of the main entry point ofthe BTT includes replacing a buzzer or pager emitting sound or vibrationby a light warning system. Exemplarily, FIG. 56B shows a pen 740, a LED738 mounted on a board 746 and a LED 739 mounted on said pen 740, asensor 750, and a processor 742. Wire 744 connects the pen 740 to board746. The processor 742 is adapted to activate light 738, 739, whenduring scanning the BTT area, the highest temperature is found. By wayof example, as shown in FIG. 56B, this pen 740 can be mounted on a board746 next to a shelf 748 where TempAlert thermometers 752 are sold,allowing a customer to precisely locate the main entry point of the BTT.Sensor 750 of pen 740 can be for example a non-contact sensor (e.g.,Thermopile) or a contact sensor (e.g., Thermistor).

The detection of the main entry point of the BTT can also be doneautomatically. Accordingly, FIG. 57 shows a 4 by 4 sensor array 760placed at the BTT. The sensor array 760 contains 16 temperature sensors,which measure the temperature at the BTT site. Each temperature sensorT1 to T16 in the array 760 provides a temperature output. Sensor array760 is connected to microprocessor 754 which is adapted to identify thesensor in sensor array 760 with the highest temperature output, whichcorresponds to the main entry point of the tunnel. For exampletemperature sensor T6 761 is identified as providing the highesttemperature output, then the temperature of sensor T6 is displayed. Theprocessor 754 continually searches for the highest temperature output ofsensor array 760 in an automated manner and the highest temperature iscontinuously displayed.

FIG. 58A is an alternative embodiment showing support structure 758comprised of a piece of silicone molded to fit the BTT area with saidsupport structure 758 containing wire 769 and sensor 770 in itsstructure. FIG. 58B shows the support structure 758 with sensor 770positioned at the BTT area 775 with wire 769 exiting the molded piece ofsilicone structure 758 toward the forehead 773. Now referring to FIG.58C, support structure 758 can alternatively include a multilayerstructure comprised of a Mylar surface 762, sensor 770 with wire 769,and silicone piece 774 in the shape of a cup that encapsulates sensor770, allowing proper and stable positioning of sensor 770 at the BTTarea.

It is also an object of the invention to provide methods and devices fortreating and/or preventing temperature disturbances. As shown in FIG. 2Bthe brain is completely insulated on all sides with the exception at theentrance of the BTT. The BTT is a thermal energy tunnel in which thermalenergy can flow in a bidirectional manner and therefore heat can beremoved from the brain or delivered to the brain by externally placing adevice at the entrance of the BTT that either delivers heat or removesheat. Accordingly, FIG. 59 shows the bidirectional flow of thermalenergy represented by arrows 780 carrying heat to the brain and arrow782 removing heat from the brain with the distribution of heat to andfrom the brain 784 occurring via the thermal storage area 786, with saidthermal storage area shown in FIG. 2B in the center of the brain. Fromthe thermal storage area 786 the thermal energy represented as hot orcold blood is distributed throughout the brain tissue 784 by the bloodvessels 788, for treating and/or preventing hyperthermia (heatstroke) orhypothermia.

Accordingly, another object of this invention is to provide a new andnovel BTT thermal pad for the application of cold or heat to the BTTarea for cooling or heating the brain.

A further object of this invention is to provide a new and novel BTTthermal pad which covers the entrance of the BTT area, which may extendto other areas of the face. However, since the brain is insulated on allother sides but at the BTT entrance, the cooling is only external anddoes not reach the brain, which could be at “frying” temperature despitethe external cooling sensation. Considering that, a preferred embodimentincludes an extended BTT thermal pad covering the face in which only theBTT area is exposed to the cold and the remainder of the extended BTTthermal pad covering the face is insulated, preventing the warming up ofthe gel or ice placed inside the bag. The BTT thermal pad container caninclude a radiant heat-reflecting film over various portions thereof,and an insulator over the same or other portions and which togetherfacilitate directional cooling. Thus, only heat conducted by the BTT isabsorbed as the BTT is cooled.

The BTT thermal device applied to the BTT area promotes selective braincooling or selective brain heating for treating hyperthermia andhypothermia respectively. The brain, which is the most sensitive organto thermally induced damage, can be protected by applying heat via theBTT during hypothermia or removing heat during hyperthermia. The coolingor heating is selective since the temperature of the remaining body maynot need to be changed, this is particularly important when cooling thebrain for treating patients with stroke or any brain damage. Themajority of the brain tissue is water and the removal or application ofheat necessary to cool or heat the brain can be precisely calculatedusing well known formulas based on BTU (British thermal unit). A BTU isthe amount of energy needed to raise the temperature of a pound of water1 degree F., when a pound of water cools 1 F, it releases 1 BTU.

The BTT thermal pad for therapeutic treatment of excessive heat orexcessive cold in the brain preferably includes a bag having asubstantially comma, banana, or boomerang shape, with said bag incomplete overlying relationship with the entire entrance of the BTT,said bag including an outer wall and an inner wall defining a sealedcavity to be filled with ice, gel-like material, solid material, and thelike, for cooling or heating the BTT skin area overlying the entrance ofthe BTT.

An exemplary brain cooling or brain heating device includes hot and coldpad or pack adapted to fit and match the special geometry of theentrance of the BTT and comprising a preferably flexible and sealed padand a gel within said pad, said gel being comprised of a mixture ofwater, a freezing point depressant selected from the group consisting ofpropylene glycol, glycerine, and mixtures thereof associated with othercompounds such as sodium polyacrylate, benzoate of soda,hydroxibenzoate, and mixtures thereof and a thickening agent. Any othercooling or heating device or chemical compounds and gels including acombination of ammonium nitrate and water can be used as cooling agentas well as heating agents such as a combination of iron powder, water,activated carbon, vermiculite, salt and Purge natural mineral powder.Those compounds are commercially available from many vendors (e.g.,trade name ACE from Becton-Dickson).

FIG. 60A shows a diagrammatic view of a preferred dual BTT thermal padalso referred to herein as BTT cold/hot pack 790 located next to eye798, 802 including a dual bag system 792, 794 for both the right andleft sides connected by connector 796. FIG. 60B shows in more detail aperspective view of the single bag BTT cold/hot pack device 810,represented by a device to be applied to the left-side, comprisingpreferably a generally comma-shape, boomerang-shape or banana-shape padwhich is sealed in a conventional fashion at its ends 812 to enclose aquantity of a gel-like material 800 which fills the pad 814 sufficientlyto enable said pad 814 to be closely conformed to the special topographyof the BTT area in the recess between the eye and nose. FIG. 60C is anopposite perspective view showing an extension 816 that conforms to therecess at the BTT area of pad 814 containing gel 800. The device isreferred to herein as BTT cold/hot pad or BTT cold/hot pack. Still inreference to FIG. 60C, perspective view is shown of the BTT cold/heatpack device and which is shown as being formed in a pillow-likeconfiguration which permits the molding of the BTT cold/heat pack intothe BTT area.

In use the BTT thermal pad would be put into a freezer or other chillingdevice for use as a cold compress or would be put into hot water to beused as a hot compress. The BTT thermal pad preferably comprises a toughflexible envelope of plastic material. The material within the BTTthermal pad is preferably a gel which will maintain its gel-likeconsistency over a wide range of temperatures. There exist many gelswhich can be cooled to freezing and which absorb heat during warmup.There are a number of different types of such gels. Some of them freezesolid, and some are flexible even at 0 degrees F. Cold packs such as afrozen water-alcohol mixture can also be used. Alternatively, a BTTthermal pad includes a bag having inner and outer walls lined interiorlywith plastic which define a cavity to be filled with ice through anopening in the bag. In this instance the bag is preferably sealed with arubber material.

Although flexible plastic is described as a preferred material forcontaining the gel, it is understood that any material or fabric can beused including vinyl, cotton, rayon, rubber, thermoplastic, syntheticpolymers, mixtures of materials, and the like. The size and shape of theBTT pad structure is adapted to fit the special anatomy of the recessbetween eye and nose and for matching the special geometry of theentrance of the BTT.

Any cooling or heating device known in the art can be used in the BTTpad treatment device including hot or cold water flowing through tubesthat are adapted to carry or deliver heat to the BTT area. The tubes canbe mounted in any head gear or the frame of eyeglasses, pumpingmechanisms can be mounted in the head gear or eyeglasses for providing acontinuous flow of water through the tubes. The BTT pad can be connectedto tubes which have connectors for joining to a water temperaturecontrol and circulating unit in the head gear or eyeglasses. Hot or coldliquid is circulated through tubes which are in communication with eachother and which deliver or remove heat from the BTT.

Elastic band or hook and loop fastener can be used for securing the BTTpad in position. Any of the support structures mentioned herein can beused to secure the BTT pad in position including a piece of glue. Forexample, the BTT pad can include a clip like mechanism or the BTTthermal pad can be secured to the frame of eyeglasses. Nose pads ofeyeglasses or modified nose pads of eyeglasses can include cooling orheating devices for delivering or removing heat from the BTT. A BTTthermal pad can include a stick mounted in the pad that can held by handand manually placed in the BTT area, for example held by a player duringa break in the game to reduce the temperature in the brain, or forwarming up the brain of a skier during a winter competition.

An alternative embodiment includes a BTT thermal pad attached to a headgear for supplying water to evaporatively cool the BTT area. In thisinstance the cold water is generated by evaporative cooling in theheadband and forehead and upper portion of a wearer's head.

Any cooling or heating device can be used to cool or heat the BTT areafor selective brain cooling or brain heating, preferably using amoldable device that conforms to the anatomy of the region at theentrance of the BTT, with directional temperature control properties forcooling or heating the skin at the entrance of the BTT. Any of thedevices for heating or overheating or for cooling, including electrical,chips, semiconductor, polymers, and the like known in the art as well asdescribed by Abreu in U.S. Pat. Nos. 6,120,460; 6,312,393 and 6,544,193,herein incorporated in their entirety by reference, and other pendingapplications by Abreu can be adapted in support structures forpositioning at the BTT entrance and used for cooling or heating thebrain.

The present invention provides a moldable BTT thermal pad or BTT thermalpack in a packaging arrangement that can provide surfaces of differingthermal conductivities and heat reflecting properties so as to prolongthe useful cooling/heating time thereof. The construction and materialsof the BTT thermal pad or BTT thermal pack permits the molding of itsshape and the retention thereof to the BTT site on the skin between theeye and nose. The materials disclosed herein can remain flexible plasticfor temperatures in the range of −10° C. to 140° C.

Referring to FIG. 61, a frontal view of an alternative embodiment of BTTthermal pack 820 is shown including a bag 822 with gel 800 with said baghaving two parts with the first part 824 positioned at the main portionof BTT 824 and containing the highest amount of gel 800 and a secondpart 826 positioned at the peripheral portion of the BTT and containinga smaller amount of gel.

FIG. 62 shows a cross sectional view of the bag 828 of the BTT thermalpack containing gel 800 with said bag sealed in its ends 832, 834.

It is understood that a ring shape surrounding the eye can also be usedor a shape that includes other parts of the face/forehead as long asthere is conformation and apposition of part of the BTT thermal pack tothe BTT area. The preferred shape and dimension matches the specialgeometry of the BTT area described herein.

FIG. 63A shows a preferred embodiment of the BTT thermal pack 830 in itsrelaxed state that includes a hard upper part 836 made preferably ofhard rubber or plastic attached to a bag 838 made of soft plastic withsaid bag containing gel 800 and being deformable upon external pressure.As depicted in FIG. 63B, the BTT thermal pack 830 is shown with acentrally formed convex shape 842 at the opposite end of hard upper part836 upon compression shown by arrows 844 to conform to the BTT anatomy840 between eye 852 and nose 854 of person 100.

The BTT thermal pack is preferably moldable and the container or bagconstructed with materials that are deformable and otherwise pliableover the temperature range of use so as to conform to the anatomy of theBTT area. A central convex area in the pack allows for intimateinteraction and thermal energy transfer at the entrance of the BTT, butit is to be recognized that the specific shape of the convex area of theBTT cold/heat pack itself can be slightly varied according to the ethnicgroup.

FIG. 64A shows a side cross-sectional view of a head 856 of person 100with BTT thermal pack 850 in a pillow-like configuration located at theBTT site 858. Construction of BTT thermal pack is performed so as tomaintain an intimate apposition to the BTT site. FIG. 64B is a frontalview of BTT hot/cold pack 850 shown in FIG. 64A at the BTT site 858located next to the left eye 862.

FIG. 65 shows a perspective view of a BTT thermal pack 860 that includesa bag 864 containing gel 800 and a rod 866 for manually holding said BTTpack 860 at the BTT site. FIG. 66 shows a frontal view of a dual bag BTTthermal pack 870 with bags 872, 874 connected to a rod 880 by flexiblewires 876, 878.

FIG. 67A shows a BTT thermal mask 880 with openings 884 for the eyes and886 for the nose and comprised of a pouch containing gel 800, andincluding bags 888, 890 for matching the anatomy of the BTT area. Theremainder of the mask 880 comprises flat area 892. The flat area 892 ispreferably insulated for allowing directional thermal energy flow, sothe gel 800 only touches the skin at the BTT area. FIG. 67B is across-sectional side view of mask 880 showing pouch 894 with bags 888,890 and the remaining flat area 892.

FIG. 67C is a schematic view of BTT thermal mask 898 with pouches 895,896 which allow intimate apposition to the BTT area being worn by user897.

FIG. 68A is a perspective view showing the BTT thermal pack 900 beingapplied to the BTT area by support structure comprised of eyewear 902being worn by user 903. FIG. 68B is a perspective frontal view of a BTThot/cold pack 930 with dual bags 932, 934 for right and left BTT andconnected by an arm 936 working as a clip to secure a hot/cold pack inplace on the BTT of user 938.

The brain cooling or brain heating device in accordance with theprinciples of the invention includes hot and cold pad or pack adapted tofit and match the special geometry of the entrance of the BTT andcomprising a preferably flexible and sealed pad and a gel within saidpad, with the surface touching the skin having a substantially convexshape. Accordingly, FIG. 69A is a perspective side view of BTT thermalpack 910 and bulging substantially convex part 906 which rests againstthe skin and conforms to the anatomy of the BTT. FIG. 69B is aperspective inferior view of BTT hot/cold pack 910 and bulgingsubstantially convex part 906 which rests against the skin and conformsto the anatomy of the BTT. FIG. 69C is a perspective planar view of BTThot/cold pack 910 and substantially flat part 912 which faces theoutside and does not touch the skin. FIG. 69D is a perspective view ofhot/cold pack 910 with gel 909 being applied to the BTT area of user911.

A tube fit to match the special geometry of the BTT site and anatomy ofthe region with circulating water can also be use for selectivelycooling or heating the brain.

The BTT thermal pack can include a bag so as to avoid direct contactwith the skin depending on the chemical compound used, such as heatingagent to prevent any thermal injury to the skin.

It is understood that a combination temperature sensor and BTT cold/heatpack can be implemented and positioned in place using the supportstructures described herein such as eyeglasses and any head mountedgear. The nose pads of eyeglasses can have a combination of a heat flowsensor to determine how fast heat is being pulled. The gradient forinstance across a thin piece of Mylar indicates the direction of heatflow. It is also understood that the right nose pad of the eyeglasseshave a temperature sensor and the left side has the cooling/heatingdevice that applies or removes heat according to the temperaturemeasured on the opposite side.

It is also understood that many variations are evident to one ofordinary skill in the art and are within the scope of the invention. Forinstance, one can place a sensor on the skin at the BTT site andsubsequently place an adhesive tape on top of said sensor to secure thesensor in position at the BTT site. Thus in this embodiment the sensordoes not need to have an adhesive surface nor a support structurepermanently connected to said sensor.

A plurality of hand held devices with non-contact or contact sensors canmeasure the brain temperature at the BTT for single or continuousmeasurement and are referred to herein as Brain Thermometers orBrainTemp devices. Accordingly, FIG. 70 shows an array 1000 of infraredsensors 1002 viewing the BTT entrance 1004 which are mounted in ahousing 1006 containing a lens 1008 to focus the radiation 1010 onsensor array 1000 in a manner such as that the sensor array 1000 viewsonly the skin at the entrance of the BTT 1004 and a microprocessor 1012adapted to select the highest temperature value read by an infraredsensor 1002 in the array 1000 with the highest value being displayed ondisplay 1014. Exemplary infrared sensors for the array 1000 includethermopile, thermocouples, pyroelectric sensors, and the like. Processor1012 processes the signal and displays in display 1014 the highesttemperature value measured by the sensor 1002 in the array 1000. FIG.71A shows another embodiment comprising of a non-contact measuringsystem that includes a housing 1022 containing a single infrared sensor1018 (e.g., thermopile), a lens 1016 to focus the radiation 1010 of theBTT area 1004 into the sensor 1018, a transmitter 1019, and an ambienttemperature sensor 1020 used to adjust the temperature reading accordingto the ambient temperature, and processing 1012 and display means 1014to process the signal and display a temperature value in addition towire 1015 connected to an external module 1017 with said moduleincluding a processor 1013 adapted to further process the signal such asprocessing spectroscopic measurements, chemical measurements, andtemperature measurements with said module 1017 adapted yet to displayand transmit the value calculated by processor 1013 including wirelesstransmission and transmission over a distributed computer network suchas the internet. An alternative for the pen-like systems in accordancewith the invention and in accordance to FIG. 71A, as shown in FIG. 71B,includes a bulging part 1024 with a substantially convex shape at theend 1030 that touches the skin 1026 and matches the concave anatomy ofthe skin 1026 entrance of the BTT 1028. The bulging convex end 1024touching the skin 1026 helps to stretch the skin 1026 and allow betteremissivity of radiation in certain skin conditions, allowing the systemto measure temperature in the skin of the BTT area at optimal conditionsand with any type of skin.

An exemplary lens system for viewing thermal radiation coming from theBTT can include exemplarily 25 sensors for reading at 1 inch from thetip of the sensor to the skin at the BTT entrance and 100 sensor arrayfor reading radiation coming from a distance of 3 inches between skin atthe BTT and sensor tip. Preferably a five degree field of view, and mostpreferably a two to three degree field of view, and yet even a onedegree of field view is used to see the main entry point of the BTT. Thespot size (view area) of the infrared sensor is preferably between 1 and20 mm in diameter and most preferably between 3 and 15 mm in diameterwhich allows the infrared sensor to receive radiation from the BTTentrance area when said sensor is aimed at the BTT entrance area whichcorresponds to the bright spots in FIG. 1A and the red-yellow area inFIG. 1B. It is understood that an infrared device (thermopile) can beplaced at any distance and read the temperature of the BTT entrancearea, as long as the sensor is positioned in a manner to view the BTTentrance area and a lens is used focus the radiation on to thetemperature sensor.

The array is adapted to receive the temperature of the BTT area. Thetemperature signal received is less than the whole face and is not thetemperature of the face, nor the temperature of the forehead. Thetemperature signal comes from the BTT, one particular area of specialgeometry around the medial corner of the eye and medial aspect of theupper eyelid below the eyebrow. This said temperature signal from theBTT can be acquired by contact sensors (e.g., thermistors), non contactsensors (e.g., thermopile), and infrared thermal imaging. This saidtemperature signal can be fed into a processor to act upon an article ofmanufacturing that can remove or transfer heat as shown in FIG. 73. Withsaid article being activated by the temperature level measured at theBTT by a hand held single measuring device, a continuous temperaturemeasuring device, and any of the devices of the present invention. Inaddition, the temperature level signal can activate another device andactivate a function of said device. The temperature level measured bythe hand held devices can be automatically transmitted by wireless orwired transmission means to a receiver.

FIG. 71C shows another embodiment comprising a non-contact measuringsystem that includes a housing 1032 containing a single infrared sensor1034 (e.g., thermopile), a columnar extension 1036 housing a window 1039and cavity 1038 to focus the radiation 1010 of the BTT area 1004 intothe sensor 1034 which is located about 3 cm from the window 1039 ofcolumnar extension 1036 in addition to an amplifier 1040, processingdevice 1042 and display device 1044 to process the signal and displaythe temperature value. The columnar extension may have a widthwisedimension, either as a cylinder, rectangle, or square, of less than 3mm, preferably less than 2.5 mm and most preferably less than 2.0 mm.

A retractable ruler 1046 is mounted in the housing 1032 and the tip ofsaid ruler can rest on the face and used for assuring proper distanceand direction of the housing in relation to the BTT for optimal view ofthe BTT area. It is understood that any measuring and positioning meansfor optimizing view of the BTT by the sensor can be used and are withinthe scope of the present invention. It is understood that anypositioning device to establish a fixed relationship between the sensorand BTT are within the scope of the invention.

FIG. 72 is a schematic view of another embodiment preferably used as asingle measurement by touching the skin at the BTT with a contacttemperature sensor. Accordingly, FIG. 72 shows a pen-like housing 1050with a sensor 1052 (e.g., thermistor) encapsulated by an insulating tip1054 with a substantially convex external shape to conform to the BTTarea and further including wire 1055 connecting sensor 1052 to processor1056, which is in electrical connection to LCD display 1058, LED 1060,and piezoelectric device 1062. In use the sensor 1052 touches the skinat the BTT entrance area 1004 generating a voltage corresponding to thetemperature, which is fed into the processor 1056 which in turnactivates LED 1060 and device 1062 when the highest temperature over thetime of measurement is achieved, and subsequently displays thetemperature in display. The sensor 1052 and encapsulating tip 1054 canbe covered by the disposable cap with a convex external surface thatconforms to the convex tip 1054.

The temperature signal from sensor 1052 can be converted to an audiosignal emitted by the piezoelectric device 1062 with said audiofrequency proportional to the temperature level measured. In additionprocessor 1056 in the housing 1050 is adapted to lock in the highestfrequency audio signal (which represents the highest temperature) whilethe user scans the BTT area. Furthermore, LED 1060 in the housing 1050can be activated when the highest temperature level is reached, and thenthe value is displayed in display 1058.

It is understood that any article of manufacture that transfers heat orremoves heat from the body in a direct or indirect fashion can be usedin accordance with the principles of the invention. Accordingly FIG. 73shows other exemplary embodiments including a sensing device representedby a non-contact sensing device 1070 such a thermopile housed in a handheld device or a contact sensing device 1072 such as a thermistor housedin a patch measuring temperature in the BTT area which are coupled bywires or wireless transmission means shown previously to an article ofmanufacture such as mattress 1078 or a collar 1080 which can alter itsown temperature or the temperature in the vicinity of said articles 1078and 1080. Exemplary embodiments include a mattress 1078 which is adaptedby electrical means to change its temperature in accordance with thesignal received from the temperature sensor 1070 and 1072 measuringtemperature in the BTT area and an article around the neck such as acollar 1080. Articles 1078 and 1080 are provided with a serpentine tube1074 and 1076 respectively, which run cold or hot water for removing ordelivering heat to the body by mattress 1078 or to the neck and head bycollar 1080, with said water system of mattress 1078 having a valve 1082and of collar 1080 having valve 1083 which is controlled by a processor1084 and 1085 respectively. Processor 1084 of mattress 1078 andprocessor 1085 of collar 1080 are adapted to open or close the valve1082 or 1083 based on the temperature level at the BTT measured bysensor 1070 and 1072. The signal of the temperature sensor 1070 and 1072controls the valves 1082 and 1083 that will open to allow cold fluid tofill a mattress when the signal from the sensor 1070 or 1072 indicateshigh body temperature (e.g., temperature equal or higher than 100.5degrees Fahrenheit). Likewise, when the signal from the sensor 1070 or1072 indicates low body temperature (e.g., temperature lower than 96.8degrees Fahrenheit) the signal from said sensors 1070 and 1072 opens thevalve 1082 and 1083 that allows warm fluid to fill the mattress 1078 andcollar 1080. It is understood that any garment, gear, clothing, helmets,head mounted gear, eyewear, hats, and the like can function as anarticle of manufacture in which heat is removed or transferred toachieve thermal comfort of the wearer based on the temperature of theBTT area. It is also understood that any sensor, contact (e.g.,thermistor) or non-contact (e.g., thermopile or thermal image sensingsystem), measuring temperature at the BTT can be used to control anarticle of manufacture removing or transferring heat to a body orphysical matter. It is further understood that the article ofmanufacturing includes infusion lines capable of delivering warm or coldfluid into a vein of a patient in accordance with the temperature at theskin around the medial corner of the eye and eyelid, which correspondsto the entrance of the BTT. Other exemplary articles of manufactureinclude shoes, floor with heating or cooling systems, electricaldraping, in-line fluid warmers, and the like.

In the embodiment in which a contact sensor touching the skin is used,the probe head can be covered with a disposable cap, such as a piece ofpolymer preferably with good thermal conductivity, with the shape of thedisposable cap to match the shape of the various probes in accordancewith the principles and disclosure of the present invention.

In addition to measuring, storing, and transmitting biologicalparameters, the various apparatus of the present invention such aspatches, eyewear, rings, contact lens, and the like include anidentification and historical record acquisition and storage device forstoring the user's identification and historical data preferably using aprogrammable rewritable electronic module in which data can be changed,added, or deleted from the module. The identification and historicaldata alone or in conjunction with the biological data (such as braintemperature and chemical measurements as glucose level and presence ofantibodies) are transmitted preferably by wireless transmission to amonitoring station. Accordingly FIG. 74 shows a schematic view of theapparatus and system for biological monitoring, identification, andhistorical data used by an animal. It is understood that the systemdisclosed is applicable to humans as well as animals.

FIG. 74 is the schematic of a preferred embodiment for four leggedcreatures showing an exemplary comprehensive system that includes: aneye ring transmitter device 1501 with said eye loop or eye ring 1501preferably including antenna 1500, sensor 1502, microprocessing,transmitting and memory module 1504, and power source 1503 with saidring placed on the eye preferably in the periphery of the eye in theeyelid pocket 1516; a collar 1520 with said collar 1520 preferablycontaining power source 1506, microprocessing, transmitting, and memorymodule 1508, and GPS transmission system 1510 coupled by wireless waves1512 to orbiting satellites 1514 and module 1508 in bidirectionalcommunication by wireless waves 1522 to module 1504 of ring 1501 topower ring 1501 and collect data from ring 1501 with said module 1508 incommunication by radio waves 1511 to external radio receiving station1509 and receiving antenna 1513; an externally placed receiver 1518 andantenna 1519 which receives the signal from module 1504 of ring 1501;and an external antenna 1524 located for instance in a feed lotconnected to computer 1526 with said antenna 1524 in bidirectionalcommunication with module 1504 of ring 1501.

Each eye ring 1501 has a unique serial number permanently or temporarilyembedded to identify the animal remotely. A 24 hour temperature log issent at each transmission, most preferably 6-12 times per day. A uniqueone-way statistical broadcast network architecture allows all members ofthe herd to share one frequency and one set of data receivers. Thereceiver is designed to receive temperature telemetry data from anetwork of livestock eye ring telemetry units and forward it to acollection computer for storage, display, and monitoring.

Although various communication and power systems are shown in FIG. 74,it is understood that the system can work with only one apparatus, forinstance ring 1501 sending a signal to receiver 1518 and antenna 1519for further processing and display, or preferably ring 1501 transmittingdata to module 1508 of collar 1520 which working as a booster radiotransmitter transmits the signal to antenna 1513 and remote station 1509for processing, monitoring, and displaying the data.

It is understood that besides an active system with a battery working asthe power source, a passive system in which the ring 1501 is powered byan external source such as electromagnetic induction provided by collar1520 or antenna 1524 can be used. It is further understood that a hybridsystem that includes both a power source comprised of battery 1503 and apassive system in module 1504 can be used in which module 1504 containsan antenna for receiving electromagnetic energy from module 1508 ofcollar 1520. In this embodiment the active part of the system using thememory in module 1504 powered by battery 1503 collects data from asensor 1502 (e.g., thermistor) and stores the data in a memory chip inmodule 1504. The passive system containing antenna in module 1504 can bealso activated when the four legged creature passes by a couplingantenna 1524, such as for instance an antenna placed in feed lots. Afterthere is a coupling between the passive system 1504 in the ring 1501 andthe external antenna 1524 in the feedlot, the data stored in the memorychip of module 1504 of the ring 1501 is received by the external antenna1524 and transferred to a second memory chip 1523 that is part of themodule external antenna 1524. The processor of module 1504 in the ring1501 is adapted to transfer the stored data any time that there is acoupling with the external antenna 1524. A variety of inductive couplingschemes previously mentioned can be used for powering and collectingdata from eye ring 1501 by antenna 1523 and 1509.

The data from a plurality of mammals (e.g., cattle) is transmitted to areceiving system. Preferably only one animal transmits at a specifictime (equivalent to having only one animal in the system) to avoid datacollisions in the form of interference that prevents successful wirelesstransmission of the biological parameters. Two exemplary schemes can beused, polling and broadcast. The polling approach requires each animalto be equipped with a receiver which receives an individual serialnumber request for data from a central location and triggers thatanimal's transmitter to send the data log. The other approach is abroadcast system, whereby each animal independently broadcasts its datalog. The problem is to avoid collisions, that is, more than one animaltransmitting at a time, which could prevent successful data transfer.Each animal transmitter will preferably transmit at a certain time andthe receiver is adapted to receive the signal from each animal at atime.

The ring 1501 can yet include a solar battery arranged to capture sunlight, digital transmission 16 bit ID# to identify the animal and trackthe animal throughout life. Preferred dimensions for outer diameter ofring 1501 for use in livestock are between 40 and 45 mm, preferablybetween 35 and 40 mm, and most preferably between 30 and 35 mm or lessthan 30 mm. For large animals such as an elephant, such as to detectmoment of ovulation for artificial insemination and birth in captivity,the preferred outer diameter is between 90 and 100 mm, preferablybetween 75 and 90 mm, and most preferably between 50 and 75 mm or lessthan 50 mm. Preferred largest dimension of ring including circuit boardand battery for livestock is between 15 and 20 mm, preferably between 10and 15 mm, and most preferably less than 10 mm, and for large animals afactor of 10 to 15 mm is added to achieve optimal dimensions. Thepreferred height of the ring 1501 for livestock is between 9 and 12 mm,preferably 6 and 9 mm, and most preferably less than 5 mm, and for largeanimals a factor of 5 mm is added to achieve optimal dimensions. Thepreferred embodiment includes hardware disposed in one quadrant of thering which contains the sensor and is located in the inferior eyelidpocket.

An alarm is activated when certain pre-set temperature limits arereached. The system of the invention can also be used with temperaturebeing transmitted in real time for detecting the moment of heat inanimals, which starts when the body temperature of the animal starts torise. The method includes detection of heat, and then inseminating theanimals preferably between 6 to 12 hours after initial detection ofheat, and most preferably between 4 and 8 hours after heat detection.

Preferably the temperature data stored over time (e.g., 24 hours) bymodule 1504 or 1508 is then downloaded to a computer system such ascomputer 1526 adapted to identify thermal signatures. Thermal signaturesare representations of the temperature changes occurring over time andthat reflect a particular biological condition. Exemplary thermalsignatures are depicted in FIGS. 75A to 75E. FIG. 75A is arepresentation of a viral infection in which there is a relatively rapidincrease in temperature, in this example there is a high temperaturewhich corresponds to a pox virus infection such as foot and mouthdisease. On the other hand a slow increase in temperature over 6 to 8hours can indicate a thermal signature for hyperthermia due to hotweather, as shown in FIG. 75B. FIG. 75C shows a rapid increase intemperature reflecting bacterial infection, with spikes followed bysustained high temperature. FIG. 75D shows a thermal signaturereflecting mastitis with a double hump in which there is an initialincrease in temperature followed by a higher increase after the firstepisode. FIG. 75E shows a thermal signature indicating heat (arrow 1544)of animals, in which there is a gradual but progressive increase of thebasal temperature. About 8 to 12 hours from beginning of heat there is afurther increase in temperature indicating the moment of ovulation(arrow 1546), with a further sustained increase in temperature in thepost-ovulation period. It is understood that a digital library ofthermal signatures can be stored and used to identify the type ofbiological condition present based on the signal received from the ringor any other sensor measuring temperature at the BTT, for both humansand animals. The thermal signature acquired by the temperature measuringsystem is matched by a processing system to a thermal signature storedin the memory of a computer and associated software for matching andrecognition of said thermal signatures. It is understood that thethermal signatures system of the present invention includes anytemperature measuring system for both animals or humans in which atemperature disturbance is present, low or high temperature.

A plurality of antenna reception scheme can be used.

FIG. 76A shows an exemplary antenna schemes arrangement 1538 including 8antennas numbered 1 to 8 in a pen which can be used to cover a herd of1000 to 2000 animals. At a particular time T1 animal 1530 transmits thedata which is captured by the closest antenna, for instance antenna1532. For animal use and to preserve power the data can be stored for 24hours and when the animal goes by one of the antennas at time T1 thedata is downloaded. When there is fever or a change in biologicalparameter the transmitting ring transmits the data continuously.Otherwise the ring only transmits data once a day. The antenna schemealso can be used as a locator of the animal. The pen and antenna schemeis plotted in a computer screen and depicted on the screen, and byidentifying the antennas receiving the signal the animal can be locatedwith the location highlighted in the computer screen. In FIG. 76Aantennas 1534 and 1532 are receiving the signal whereas antenna 1536 isnot receiving the signal since antenna 1536 is distant from the animal.Therefore animal 1530 is located in the area covered by antenna 1532 and1534. FIG. 76B shows the precise location using a radio receiverdirection finder, in which a radio receiver 1540 is carried by a farmeror located in the vicinity of the area covered by antennas 1532 and 1534which contains animal with fever 1530 as well as healthy animals 1542 a,1542 b, 1542 c. Since animal 1530 is the only one emitting signalcontinuously, radio receiver 1540 can precisely identify sick animal1530 among healthy animals. The ID of animal 1530 is transmitted inconjunction with the biological data for further identification ofanimal 1530. Alternatively, a farmer uses an electromagnetic hand heldexternal power switch next to the animal to activate the circuit in theeye ring 1501 in order to manually initiate transmission of data to areceiver for further processing. Any lost animal could also be locatedwith the present invention and an animal which ran from the pen could beidentified as not emitting a signal within the pen.

Although a multiple antenna scheme is shown in FIG. 76A, the preferredembodiment includes an antenna 1513 or alternatively antenna 1519, and aweatherproof metal cased receiver unit with radio receiver module,computer interface, and power source such as receiver 1509 oralternatively receiver 1518.

When using a rewritable or programmable identification serial number,the eye ring 1501 can be reused and a new serial identification numberprogrammed and written for said eye loop or eye ring 1501.

Although a ring in the eyelid pocket is shown, it is understood thatanother method and device includes a temperature signal coming from theBTT of cattle external to the eye which is located in the anteriorcorner of the eye (corner of the eye in animals is located in the mostfrontal part of the eye) with said signal being captured by contact ornon contact temperature sensors as well as thermal imaging.

The signal from eye ring 1501 can preferably automatically activateanother device. By way of illustration, a sprinkler system can beadapted to be activated by a radio signal from eye ring 1501 with saidsprinkler system spraying cold water and cooling off the animal when ahigh body temperature signal is transmitted by eye ring 1501.

A variety of diseases can be monitored and detected by the apparatus ofthe invention. By way of illustration, a characteristic increase inbrain temperature can detect foot-and-mouth disease, babesiosis,botulism, rabies, brucellosis, and any other disorder characterized bychanges in temperature as well as detection of disorders by chemical andphysical evaluation such as detection of prions in the eyelid or eyesurface of an infected animal using antibodies against such prions andcreating an identifiable label such as fluorescence or by generating amechanical or electrical signal at the time of antigen-antibodyinteraction. Prions can cause bovine spongiform encephalopathy knownalso as “mad cow” disease and such prions can be present in the eye andcan be detected by using an immobilized antibody contained in the eyering against such prion or a product of such prion. By detectingmastitis (or an animal with fever) which is scheduled for milking, thepresent invention provides a method to prevent contaminating otheranimals being milked by generating a sequence for milking in which theanimal with fever is milked last. This will avoid contaminatingequipment with a sick animal and with said equipment being sequentiallyused in other healthy animals.

The present invention provides continuous monitoring of animals 24 hoursa day from birth to slaughter with automatic analysis and detection ofany disease that can cause a threat to human health or animal health,besides identification and location of the sick animal. Therefore withthe present invention an animal with disease would not reach theconsumer's table. The present invention therefore includes a method toincrease food safety and to increase the value of the meat beingconsumed. The system of continuous disease monitoring is called DM24/7(disease monitoring 24/7) and includes monitoring the biologicalvariable 24 hours seven days a week from birth to slaughter, feeding theinformation into a computer system and recording that information. Anymeat coming from an animal monitored with DM24/7 receives a seal called“Monitored Meat”. This seal implies that the animal was monitoredthroughout life for the presence of infectious diseases. Any user buying“Monitored Meat” can log on the internet, and after entering the number(ID) of the meat which can be found in the package of the meat beingpurchased. Said user can have access to the thermal life and biologicalmonitoring of the animal and for the presence of fever or disease of theanimal which the meat was derived from. The method and device includes avideo stream associated with the ID of the animal with said video orpictures showing the farm and information on the farm where the animalcame from or the meat pack facility where the animal was processed,providing therefore a complete set of information about the animal andconditions in which such animal was raised. Besides viewing over theinternet, at a private location such as at home, the system may alsoprovide information at the point of sale. Accordingly, whenever the userpurchases the product and a bar code for the product for instance isscanned, a video or photos of the farm or the company packing the meatappear on a screen at the point of sale. This method can be used whenpurchasing any other product and preferably allows the consumer to useidle time in the cashier's station to become more familiar with theproduct purchased.

Preferably the ring has a temperature sensor covered by insulatingmaterial (eg. polyurethane) in one end and with an exposed surface atthe other end. The preferred measuring method uses the measuring surfacefacing the outer part of the anatomy of the eye pocket and theinsulating part facing the inner part of the eyelid pocket.

The eye ring contains memory means for storing on a permanent ortemporary basis a unique identification number that identifies theanimal being monitored. The ID code in the processor of the ring istransmitted to a receiver as an individual number only foridentification and tracking purposes or associated with a temperaturevalue or other biological variable value. The memory chip in the ringcan also contain the life history of the animal and historical dataincluding weight, vaccines, birth date, birth location, gender,diseases, genetic make up, and the like.

Range of the entrance of BTT area is about 30 square cm and the generalmain entry point is 25 square cm and encompasses the medial corner ofthe eye and the area of the eyelid adjacent to the eyelid margin. Thecorrelation coefficient between temperature at the BTT area and the coretemperature reflecting the thermal status of the brain is 0.9. Insteadof using the whole face, the method for infrared or thermal imagingsensing as well as contact sensor includes a temperature signal whichcomes specifically from the BTT area, and the hottest spot in BTT areais then located and used as a source signal to activate another deviceor to deploy an action.

It is understood that an infrared thermal imaging camera can also beused and the point source emitting the highest amount of radiation fromthe entrance of the BTT is selected by the processor in the camera andthe temperature level corresponding to the point source with highestthermal energy is displayed in the display. Exemplary infrared camerasinclude the BTT Thermoscan of the present invention.

The BTT Thermoscan of the present invention is adapted to view theentrance of the BTT around the medial corner of the eye, with the viewof the sensor, by way of a lens, matching the entrance of the BTT areadisplayed in FIGS. 1A and 1B, and in FIGS. 3A to 9. Exemplaryoperational flow for measuring the temperature at the BTT with a thermalimaging system includes the first step of viewing the entrance of theBTT by radiation detector in the camera and a processor adapted to,after the first step, to search for the point source in the thermalimage of the BTT with the highest emission of thermal radiation. In thefollowing step the temperature of the point source in the thermal imageof the BTT with the highest amount of radiation is calculated, with saidcalculated temperature value preferably displayed. In the next step, thecalculated temperature value is transmitted by wire or wireless means toan article of manufacture that can remove heat or transfer heat to thebody in a direct or indirect manner. In the following step, thetemperature of the article of manufacture is adjusted in accordance withthe signal received. Exemplary articles of manufacture that transfer orremove heat from the body in an indirect manner includes the airconditioner/heater systems of vehicles. Exemplary articles ofmanufacture that transfer or removes heat from the body in a directmanner includes vehicle seats. The measuring system in accordance withthe present invention is adapted to seek for the hottest area around thecorner of the eye and eyelid. Once the hottest spot around the medialcorner of the eye and eyelid is found, a second step includes findingthe hottest spot in the area identified in the first step, which meansto find the hottest spot on the entrance of the BTT as shown in FIGS. 1Aand 1B.

Now in accordance with another preferred embodiment of the presentinvention shown in FIG. 77A to 77C, an apparatus comprised of a patchfor use in biological monitoring according to the invention comprisestwo parts: a durable part containing the sensor, electronics, and powersource and a disposable part void of any hardware with said two partsdurable and disposable being detachably coupled to each other preferablyby a hook and loop fastener material (commercially available under thetrade name VELCRO). Accordingly FIG. 77A is a schematic view showing apatch composed of two parts connected to each other by a hook and looparrangement herein referred as VELCRO Patch with said VELCRO Patch 1591including a disposable piece 1730 and durable piece 1596 with saiddurable piece 1596 housing and electrically connecting sensor 1590,power source 1594, and transmitter and processor module 1592 with VELCROsurface 1598 of durable piece 1596 detachably coupled to VELCRO surfaceof disposable piece 1730 and the external surface of said disposablepiece 1730 covered by a liner 1732 which when peeled off exposes anadhesive surface which is applied to the skin. When in use the two parts1730 and 1596 are connected and held in place by the hook and loopmaterial, and liner 1732 is removed to expose the adhesive covering theexternal surface of disposable piece 1730 with said adhesive surfacebeing applied to the skin in order to secure said VELCRO Patch 1591 tosaid skin with sensor 1590 resting adjacent to the entrance of the BTTto produce a signal representing by way of illustration the braintemperature. Although VELCRO hook and loop fastener was described as apreferred attachment between disposable and durable parts, it isunderstood that any other attachment device such as a disposable pieceattached to a durable piece by means of glue, pins, and the like can beused or any other conventional fastening device.

FIG. 77B shows the two parts of a VELCRO Patch comprised of a disposablepart 1600 which contains only VELCRO material and a durable part 1596which contains sensor 1590, power source 1594, module 1592 whichincludes a transmitter, processor, piezoelectric piece, buzzer, andspeaker, transmitter and processor module 1592, and LED 1602electrically connected by wires contained in the VELCRO material withVELCRO surface 1598 of durable piece 1596 detachably coupled to VELCROsurface 1601 of disposable piece 1600 and the external surface of saiddisposable piece 1600 covered by a liner 1604 located on the oppositeside of loop surface 1601 of disposable piece 1600 which when peeled offexposes an adhesive surface which is applied to the skin. Since thehardware housed in the durable part 1596 is relatively expensive saiddurable part 1596 with hardware is reusable while the disposable part1600 can be made relatively inexpensively since it only comprises VELCROloops and since said part is the part in contact with the skin said part1600 may be disposed of after contacting the skin or when it iscontaminated by body fluids. It is understood that the durable part caninclude a flexible plastic housing containing hardware and a disposablepart comprised of a double coated adhesive tape. It is within the scopeof the present invention to include a support structure such as a patchcomprised of two parts in which a disposable part is in contact with theskin and a durable part housing hardware and electrical circuitry is notin contact with the skin. It is yet within the scope of the invention toinclude a support structure comprised of hook and loop material such asVELCRO comprised of two parts one disposable and durable part in whichthe disposable part is in contact with the skin and the durable partcontaining pieces in addition to the VELCRO material is durable and doesnot contact the skin. By way of illustration, but not by limitation, thedurable part of the VELCRO can contain a spring load rod plate such asfound in airway dilators (trade name BreatheRight for humans and Flairfor animals) and the disposable part contains a release liner andadhesive surface which goes in contact with the skin of a human oranimal. Another illustration includes a durable part housing a containerwith fluid or chemicals to be applied to the skin and disposable partwhich goes in contact with the skin by means of an adhesive surface ormechanical fasteners such as elastic bands. Yet another illustrationincludes a watch attached to a VELCRO material working as the durablepart which contains, for instance, a sensing part for measuring glucoseand a disposable part. Preferably the VELCRO part containing the hookswork as the durable part and houses pieces other than the VELCROmaterial while the Velcro part containing the loops work as thedisposable part which preferably is in contact with the body part suchas the skin.

When applied to the skin the VELCRO Patch works as one piece withdurable and disposable parts connected by the hook and loop material andno hardware is visible on the surface of the durable part with theexception of a reporting device such as a LED to alert the user when thebiological parameters are out of range. Accordingly FIG. 77C is aschematic view showing the VELCRO Patch of FIG. 77B, with said VELCROPatch 1724 applied to the skin around the eyes 1726 and with an externalsurface of durable part 1722 containing LED 1720 which is activated byprocessor and driver module (not shown) housed in the durable part 1722of VELCRO Patch 1724.

VELCRO Patch of the present invention can further include attachmentstructure for attaching lenses to said VELCRO Patch, herein referred asVELCRO Eyewear. Accordingly FIG. 78 is a schematic view of VELCROEyewear 1710 comprised of the durable part 1712 which houses sensor1700, power source 1706 and transmitter-processor module 1704 inaddition to groove 1708 adapted to receive lens 1702 which can slide inand be secured at groove 1708. The groove mechanism of the inventionallows for any type of lens to be used and replaced as needed. Howeverit is understood that a permanent attachment of the lens 1702 to theVELCRO durable part 1712 can be used. It is also understood that theVELCRO material can be made in a way to conform to the anatomy of theface and that a variety of fastening devices previously described forattaching the lens can be used. The VELCRO Eyewear can yet have templesattached to its side for further securing to the face of the user. It isalso understood that any sensor can be used including temperature,pressure, piezoelectric sensors for detecting pulse of a blood vessel,glucose sensor, and the like.

FIG. 79A is a perspective view showing another exemplary embodiment of asupport structure 1740 comprised of a bowl-like structure with asubstantially external convex surface 1742 to conform to the anatomy ofthe BTT entrance with said support structure 1740 housing sensor 1744and electrical connection. FIG. 79B shows another embodiment of asupport structure 1748 with a substantially convex outer surface 1750 toconform to the anatomy of the BTT with structure 1748 being alsosubstantially elongated to match the geometry of the BTT entrance andfurther housing sensor 1752 and electrical connection 1754.

FIG. 80 is a cross sectional diagram of a bowl shown in FIG. 79Aincluding a holder 1756 in the shape of a bowl with an external convexsurface 1757 and a sensor 1758 protruding through the surface of thebowl holder 1756 with said sensor being in close apposition to the skin1759 at the BTT and its terminal blood vessel 1755.

FIG. 81A is a schematic top view of another preferred embodiment for thesupport structure comprised of a boomerang or banana shape patch 1760comprised of a thin insulating polyurethane layer 1766 housing a supportstructure 1762 which houses sensor 1764 with support structure 1762having a different height than layer 1766 which makes sensor 1764 toprotrude and be in higher position in relation to layer 1766. Surface oflayer 1766 contains a pressure sensitive acrylic adhesive for securingsaid patch to the skin. FIG. 81B is a schematic side view of boomerangshape patch 1760 of FIG. 81A showing the different height betweenstructure 1762, which houses sensor 1764 and wire 1765, and adhesivepolyurethane layer 1766. The preferred height difference between thestructures 1766 and 1762 is 5 mm, and preferably between 3 and 4 mm, andmost preferably between 1 and 3 mm. FIG. 81C is a perspective view ofpatch 1760 with a release liner on the sensor area 1768 and a releaseliner 1773 comprised of two pieces, a superior piece 1769 and aninferior piece 1771. FIG. 81C shows the superior piece 1769 being peeledoff to expose adhesive surface 1770. The release liner 1773 can comprisea single section or have a single or multiple slits to make a multiplesection release liner. Suitable release liners for use with an adhesivelayer are known in the art. According to this embodiment, when applyingpatch 1760 to the BTT area, sensor liner piece 1768 can be removed firstand patch 1760 is then positioned with the sensor area aligned with theentrance of the BTT. Once the proper final position of the patch 1760 isdetermined, inferior piece liner 1771 is removed and patch 1760 appliedto the nose area, and then superior piece liner 1769 can be removed andapplied to the skin above the eyelid margin. FIG. 81D is a perspectiveview showing patch 1760 being applied to the skin of user 1770 withexternal markings on patch 1760 indicating sensor position 1768 and line1772 for aligning with the corner of the eye. It is understood that thepresent invention includes a sensor arrangement within a supportstructure in which said sensor is located at a different height than thebasic larger support structure comprising the patch.

FIG. 82 is a schematic top view of eyewear showing an exemplaryelectrical arrangement for support structure comprised of modified nosepads and frame of eyewear with said frame of eyewear 1880 includingelectromagnetic switch 1774 in left lens rim 1776 and magnetic rod 1778in left temple 1882 for electrically turning the system on when inelectrical contact, transmitter and power source module 1884 in nosebridge 1886 is electrically connected by wire 1888 in lens rim 1776 toswitch 1774, and antenna 1890 in right lens rim 1892 connected to module1884. When the temples are opened for using the eyewear an electricalconnection is established between switch 1774 and magnetic rod 1778which automatically activates the system. It is understood that avariety of spring mechanisms can be integrated into a shaft holding thesensors for better apposition of said sensors to the BTT area.

The present invention provides a method for optimizing fluid intake toachieve euhydration and avoid dehydration and overhydration. The presentinvention provides a continuous noninvasive core temperature monitoring,and when the temperature reaches certain pre-set levels such asincreased temperature which reflects increased heat stored in the body,then by ingesting fluid the temperature can be lowered. Braintemperature reflects the hydration status and dehydration leads to anincrease in the core (brain) temperature. The method in accordance withthe present invention includes an algorithm for use in the situation ofdehydrated, sedentary people exposed to heat (as illustrated by theexcess mortality during heat waves), and people during physicalactivities. The invention showed that ingestion of 4 ounces of waterevery hour after body temperature reaches 100.4 degrees F. will lowerthe body temperature to 98.6 degrees F. and will keep the bodytemperature at lower than 99.5 degrees F. thus preventing the dangers ofheat stroke. In case of athletes in athletic activities such as cycling,the invention showed that ingestion with fluid containing carbohydratesand minerals (e.g., trade name PowerAde of the Coca-Cola Company) cankeep peak performance with ingestion of 6 to 8 ounces when thetemperature at the BTT reaches 99.3 degrees Fahrenheit and performanceis maintained with ingestion every 1 to 2 hours. A variety of algorithmsfor use in the situation of athletes at risk of overheating, can becreated based on the principle of the invention. Special size containersfor fluid or water can be used by an athlete who is aware of the fluidintake needed during a competition.

A method and algorithm to couple temperature (hypothermia) tonourishment (malnutrition) in elderly and in anorexia nervosa can becreated, with the temperature level indicating malnutrition and furtherindicating what food to ingest to maintain adequate temperature. It isfurther understood that foods can be developed based on body temperatureto achieve optimal nutritional value—fresh and frozen, or processedfoods. It is yet understood that temperature changes indicatingovulation can be used as a method to create foods that increasefertility by identifying what food articles increase ovulation.

The present invention also provides methods and devices for evaluatingdiet such as caloric restriction in which the temperature indicates themetabolism and therefore a lower basal temperature indicates reducedmetabolism and metabolic waste products including monitoringcarbohydrate intake and metabolism. The present invention also providesmethods for monitoring hypoglycemia in diabetes in which lowering of thetemperature is a predictor of a hypoglycemic event. The invention alsoprovides methods for detecting pulmonary infarction and cardiac eventswhich are associated with a particular increase in temperature. Anycondition which is associated with a change in temperature can bepredicted and detected by the present invention from pregnancy disorderscoupled to hypothermia to hyperthermia in head trauma.

The present invention provides a variety of other benefits. Otherexemplary benefits include: 1. monitoring Multiple Sclerosis sinceincrease in brain temperature can lead to worsening of the condition,and a corrective measure can be taken when the present inventionidentifies such increase in temperature, such as by drinking coldliquids at the appropriate time or cooling off the brain as previouslydescribed, 2. significant differences between left and right BTT canindicate a pathological central nervous system condition, 3. detectingincreased brain temperature to reinforce diagnosis of meningitis orencephalitis and thus avoid excess use of lumbar tap in people withoutthe infection, and 4. Young babies cannot regulate their bodytemperature in the same way that adults do and can easily become toohot. Sudden Infant Death Syndrome (SIDS) is more common in babies whohave become overheated. By monitoring babies' temperature the presentinvention can alert parents in case the baby's temperature increases.

A receiver receiving signal from the sensor system of the presentinvention can be external or implantable. When implantable inside thebody the receiver can be powered by magnetic induction externally orbatteries recharged externally. The receiver receives the signal from atemperature sensor, glucose sensor, or the like and retransmits thesignals for further display.

Any transmitter of the present invention can be integrated withBluetooth, GRPS data transmission, and the like. The signal from thetransmitter then can be captured by any Bluetooth enabled device such ascell phones, electronic organizers, computers, and the like. Software ofthe cell phone can be modified to receive the coded signal from atransmitter. Algorithm in the receiver will decript the signal anddisplay the value. A cell phone can have an auto dial to call a doctorfor example when fever is noted. It is understood that the signal from acell phone or a signal directly from the transmitter of the supportstructure can be transmitted to a computer connected to the internet forfurther transmission over a distributed computer network.

The prior art used facial skin temperature as detecting means formonitoring body temperature. As seen in FIGS. 1A and 1B, temperature ofthe skin on the face varies significantly from area to area and is notrepresentative of the core temperature. In addition facial skintemperature does not deliver thermal energy in a stable fashion. Anydevice or method that uses facial skin temperature to activate anotherdevice or monitor temperature of the body will not provide a precise noraccurate response. In addition facial skin temperature does notrepresent the thermal status of the body and has a poor correlation withcore and brain temperature. The only skin surface of the body which isin direct and undisturbed communication with inside the body is thespecialized area of special geometry located at the entrance of the BTT.Any temperature sensing device placed on or adjacent to the BTT entrancecan measure core temperature in a precise and accurate manner. It isunderstood that any sensor including a calorimetric sticker such as withliquid crystal calorimetric thermometers can be used and placed on theskin at the entrance of the BTT area, and are within the scope of theinvention.

Now referring to the previously described automated climate controlsystem, an exemplary embodiment will be described in more detail.Although this exemplary preferred embodiment will be described forclimate control in the cabin of a transportation vehicle (e.g., car) itis understood that the method, device and system can apply to anyconfined environment such as home, work place, a hotel room, and thelike in which the temperature inside the confined environment isadjusted based on the temperature at the BTT for achieving thermalcomfort for the subject inside the confined environment.

The temperature measurement at the BTT represents the thermal comfort ofthe body. Investigation by the present invention showed that the thermalcomfort of the body is reduced as the temperature of the body increasesor decreases reflected by a change in brain temperature at the BTT.Thermal comfort of a human being is reflected by the skin temperature atthe BTT, with higher skin temperature at the BTT generating a hot bodysensation while a lower skin temperature at the BTT generates a coldbody sensation. In order to achieve thermal comfort for the occupants ofa cabin the system of the invention manages cabin thermal comfort fromthe temperature signal generated at the BTT. The present inventionpreferably uses a particular specialized area in the face, and not thewhole face to manage the cabin temperature and cabin thermal comfort.The present invention system preferably monitors temperature in lessthan the whole face which causes an optimal control of the heating andcooling of the cabin to achieve thermal comfort of the occupant of thecabin.

Since thermal comfort is reflected in the brain temperature adjustingthe climate cabin based on the temperature of the BTT will provide athermally comfortable environment for the occupant of the cabin. The BTTtemperature is set for controlling the HVAC (heater-air conditioner) andother parts of the vehicle previously mentioned such as seats, carpets,and the like, which are adjusted to maintain the occupant's thermalsensation in a comfortable state. In particular, articles in contact oradjacent to the body are used to automatically remove or apply heat tothe occupant's body based on the BTT signal. To further improve thermalcomfort, the system includes a temperature sensor in the cabin fordetecting cabin temperature. Accordingly, FIG. 83 shows an exemplaryautomated climate control system which includes BTT temperature sensingdevice 1894 for contact measurements (e.g., eyewear) and 1895 fornon-contact measurements (e.g., infrared detector) for monitoringtemperature at the BTT, control device 1896 adapted to automaticallyadjust articles 1898 in the cabin 1900 for removing or delivering heatbased on the signal generated by BTT sensing device 1894, a cabintemperature sensor 1902 to detect the temperature in the cabin 1900, andan article 1898 inside the cabin adapted to remove heat when the signalfrom BTT sensor 1894 indicates high temperature or to deliver heat whenthe BTT sensor 1894 indicates low temperature. Although for illustrationpurposes a vehicle seat will be used as an article forremoving/delivering heat, it is understood that other articles such asHVAC, carpet, steering wheel, and other articles previously mentionedcan be used. As soon as the vehicle is started, the cabin sensor 1902detects the cabin temperature and adjusts the article 1898 for removingor delivering heat based on the temperature signal from the cabin sensor1902. Next or simultaneous with measurement of cabin temperature bysensor 1902, the output of BTT sensor 1894 is fed into control device1896 which activates article 1898 to remove or deliver heat based on thesignal from the BTT sensor 1894. If the BTT sensor 1894 indicates HIGH(>98.8° F.) then article 1898 will remove heat, and if LOW (<97.5° F.)is detected by BTT sensor 1894 then article 1898 will deliver heat, inorder to achieve cabin thermal comfort. An exemplary embodiment forcooling includes control means 1896 connected to an air-conditioningcontrol system for managing the amount of cool air being generated andblown in a proportional manner according to the temperature level outputby BTT sensor 1894. For heating exemplarily the control device 1896 canbe connected to a control system 1906 which gradually adjusts heatdelivery by an electrically-based vehicle seat 1898 according to theoutput level by BTT sensor 1894. Control device 1896 is adapted toremain neutral and not to adjust article 1898 when temperature at theBTT is within 97.5° F. and 98.8° F. Since thermal comfort can vary fromperson to person, the system can be adapted for removing or deliveringheat according to specific temperature thresholds in accordance with theoccupant's individual needs, and not necessarily in accordance todefaults set at 97.5° F. and 98.8° F. It is understood that acombination of skin sensors placed in other parts of the body can beused in conjunction with BTT sensor 1894. It is yet understood that therate of change in the skin temperature can be accounted for and fed intomicrocontroller which is adapted to adjust articles based on a largevariation of skin temperature at the BTT site, with for instance asudden cooling of the body of more than 0.6 degrees generating acorresponding decrease in the amount of cool air being generated or evenshutting off an air conditioner system. It is also understood that BTTsensing devices include contact device (e.g., patches and eyewear of thepresent invention), non-contact devices (e.g., infrared devices of thepresent invention), thermal imaging (e.g., BTT Thermoscan of the presentinvention), and the like.

Yet another embodiment according to the present invention includes asupport structure containing a sensor to measure biological parametersconnected to a nasal strip for dilating airways of humans such asBreathe Right (commercially available under the trade name BreatheRight)and for dilating airway passages of animals (commercially availableunder the trade name Flair). Exemplary air dilator nasal strips weredescribed in U.S. Pat. Nos. 5,533,503 and 5,913,873. The presentinvention incorporates airway dilators into patches for biologicalmonitoring. The present invention can be an integral part of an airwaydilator. The airway dilators can be an extension of the presentinvention. The coupling of a patch measuring biological parameters andan air dilator is convenient and beneficial since both are useful in thesame activities. Nasal airway dilators are beneficial during sleeping,in athletic activities, or when suffering from a cold or respiratoryinfections and the patch of the present invention is used duringsleeping, monitoring temperature changes in athletic activities, andmonitoring fever during respiratory infections. Both nasal airwaydilators and the patch of the present invention use an adhesive in itsbacking to secure to the skin and both are secured to the skin over thenasal bones, the patch of BTT located in the superior aspect of thenasal bone and the air dilator preferably in the inferior aspect of thenasal bone. The nasal airway dilator extension of the patch of thepresent invention is referred to herein as BioMonitor Dilator (BMD).Accordingly, FIG. 84 is a front perspective view of a preferredembodiment showing a person 100 wearing a BMD 1908 including a supportstructure comprised of a patch 109 connected by connecting arm 1907 toair dilator nasal strip 1909 with said BMD placed on the nose 1911 withpatch 109 containing indicator lines 111 and containing an active sensor102 positioned on the skin at the end of the tunnel on the upper part ofthe nose 1911 and air dilator nasal strip 1909 positioned on the skin ofthe lower part of the nose 1911 of user 100. The embodiment of the BMD1908 shown in FIG. 84 provides transmitting device 104, processingdevice 106, AD converter 107 and sensing device 102 connected byflexible circuit 110 to power source 108 housed in patch 109. Although aconnecting arm is shown it is understood that the BMD can be made as onepiece in which the upper part houses the sensor and circuitry and thepart on the lower aspect of the nose includes a spring loaded strip toact as nasal airway dilator. The present invention discloses a method ofsimultaneous monitoring biological parameters while dilating nasalairways.

Another embodiment includes a plurality of kits shown in FIGS. 85A to85D. Accordingly, FIG. 85A is a schematic view of a kit 1910 containingan adhesive tape 1912 and a free sensor 1914 attached to a wire 1916.The free sensor 1914 is unattached to a support structure and when inuse said sensor is preferably placed in contact with the adhesive 1912in order for the sensor 1914 to be secured to the skin by the adhesivesurface of adhesive 1912. Another embodiment shown in FIG. 85B includesa kit 1918 containing a support structure 1920 such as a patch, clip,eyewear (e.g., eyeglasses, sunglasses, goggles, and safety glasses) andthe like, and receiver 1922 illustrated as a watch, but also cell phone,electronic organizer, and the like can be used as a receiver and beingpart of the kit. Kit 1918 can also house a magnet 1923 in its structurewhich acts as a switch, as previously described. It is understood thatkit 1918 can include only a patch with the magnet 1923 adjacent to saidpatch 1922. The watch 1922 preferably has a slanted surface for betterviewing during athletic activities such as during cycling with the fieldof view of the watch 1926 directed at an angle toward the face of thecyclist, so just by looking down and without turning the head the usercan see the temperature level displayed on the watch 1926. A furtherembodiment shown in FIG. 85C includes a kit 1932 containing specializedBMD patch 1928 and a receiver 1930 illustrated as a watch.

Another embodiment includes shoes with temperature sensor for detectingcold and with a radio transmitter to transmit the signal to a receiver(e.g., Watch). The signal from the shoe in conjunction with the signalfrom the TempAlert at the BTT provides a combination of preventivedevice against both frostbite and hypothermia.

It is understood that the support structure such as a patch may housevapors and when the outer surface of the patch is scratched mentholatedvapors can be released to help soothe and relieve nasal congestion,which can be convenient when monitoring fevers with the patch.

It is also understood that steel or cooper can be placed on top of asensor to increase thermal conductivity as well as any otherconventional means to increase heat transfer to a sensor.

It is understood that any electrochemical sensor, thermoelectric sensor,acoustic sensor, piezoelectric sensor, optical sensor, and the like canbe supported by the support structure for measuring biologicalparameters in accordance with the principles of the invention. It isunderstood that sensors using amperometric, potentiometric,conductometric, gravimetric, impedimetric, and fluorescent systems, andthe like can be used in the apparatus of the invention for themeasurement of biological parameters. It is also understood that otherforms for biosensing can be used such as changes in ionic conductance,enthalpy, and mass as well as immunobiointeractions and the like. It isalso understood that new materials and thermally conductive liquidcrystal polymers that produce a response in accordance to temperaturecan be used in the invention and positioned at the BTT site.

The foregoing description should be considered as illustrative only ofthe principles of the invention. Since numerous modifications andchanges will readily occur to those skilled in the art, it is notdesired to limit the invention to the exact construction and operationshown and described, and, accordingly, all suitable modifications andequivalents may be resorted to, falling within the scope of theinvention.

FIGS. 86A to 86Z show preferred embodiments for the sensing anddetecting system of the present invention. It is important to note thatdue to the specialized anatomic and physical configuration of the BrainTemperature Tunnel (BTT) as described in U.S. patent application Ser.No. 10/786,623, hereby incorporated by reference in its entirety,special dimensions and configurations of a sensing device are required,and will be reflected by the specialized dimensions and structure of thepresent invention disclosed herein. Accordingly, FIG. 86A shows thespecialized support structure 2000, referred herein as sensing device2000 which includes a specialized body 2002, which includes anessentially flexible substrate, an arm 2004, and a sensing portion suchas a measuring portion 2006.

Sensing device 2000, for purposes of illustration, is shown as comprisedof three parts, body 2002, arm 2004, and measuring portion 2006. Body2002 is demarcated by line EF and line CD. Arm 2004 is demarcated byline CD and line AB. Measuring portion 2006 is demarcated by line AB,and works as the free end of sensing device 2000. Arm 2004 is connectedto measuring portion 2006 and to body 2002. Body 2002 of the sensorsystem 2000 can preferably comprise a plate configuration, said platepreferably having essentially flexible characteristics so as to bemolded and/or to conform to a body part of a human or animal. Plate 2002can be preferably secured to a body part by adhesive or attachmentmeans. Body part for the purpose of the description includes the body ofany living creature including humans and animals of any type as well asbirds and other species such as insects. Body 2002 can also include anadhesive surface or any other fastening means, clipping means, and thelike which is used to secure body 2002 to an area adjacent to the BTT oron the BTT.

The present invention includes a support structure 2000 removablysecurable to a body part and having a sensor for measuring biologicalparameters from a brain tunnel. Any sensor, detector, sensing structure,molecule, moiety, element, radiation detector, a pair of lightemitter-detector, fluorescent element, and the like, which can sense,analyze and/or measure an analyte or tissue can be used and disposed inor on measuring portion 2006 or at the end of arm 2004, includingcontact as well as non-contact detector configurations, and all fallwithin the scope of the invention. The sensors and/or detectorspreferably are positioned on or adjacent to the upper or lower eyelid,and most preferably on or adjacent to the upper eyelid, and even morepreferably on or adjacent to an area between the eye and the eyebrow.

Sensing device 2000 preferably comprises: body 2002, which has an innersurface for disposition towards the body part and preferably includes anadhesive surface to securely attach and conform the body 2002 to a bodypart, and an outer surface for disposition away from the body part; arm2004 connected to body 2002, said arm 2004 being adjustably positionableand adapted to position sensor 2010 adjacent, on, or firmly against thebrain tunnel; and a measuring portion 2006 connected to arm 2004, saidmeasuring portion housing a sensor 2010. Body 2002 is physicallyconformable to the body part, and preferably includes an outer layer andan inner layer, the inner layer comprised of essentially soft materialand including an adhesive surface, said inner layer being attached to anouter layer, said outer layer including a flexible substrate, such as athin metal sheet, to conform to the body part and to provide stableattachment. A wire is preferably disposed on the outer layer or betweenthe inner layer and the outer layer.

Although sensing device 2000, for purposes of illustration is shown asthree parts, it is understood that sensing device 2000 can comprise anintegral device fabricated as one piece. Sensing device 2000 can alsocomprise an integral one-piece device that is fabricated as one piece,but having three different portions. In addition, for example, arm 2004and measuring portion 2006 can be considered as one piece. Anycombination of the parts, namely body, arm, and measuring portion,described herein can be used as the support structure for a sensor,molecule, or detector.

FIG. 86B shows in more detail the sensing system 2000 of FIG. 86Aincluding the specialized body 2002, the arm 2004, and the measuringportion 2006, said measuring portion 2006 housing a sensor 2010. Sensorsystem 2000 comprises preferably a plate 2002 for securing the device2000 to a body part, and further comprises an arm 2004, said arm 2004connecting supporting plate 2002 to a measuring portion 2006. Arm 2004is preferably an adjustably positionable arm, which is movable inrelation to plate 2002. Arm 2004 preferably comprises a shape memoryalloy or any material, including plastics and polymers that have memory.Preferably, arm 2004 is deformable and has a memory. The end 2026 of arm2004 terminates in the measuring portion 2006. Although arm 2004comprises preferably an adjustably positionable arm, arm 2004 can alsoinclude a rigid arm. Preferred materials for the arm 2004 include a thinsheet of metal such as stainless steel, aluminum, and the like orpolymers and plastics of various kinds. The material can also includerubber, silicone or other material. Sensor 2010 at the end of arm 2004is connected to a reading and processing circuit 2012, referred to alsoherein as a biological parameter monitor, through wire portion 2065.Sensor 2010 is electrically coupled to the biological parameter monitor,which receives a signal from sensor 2010, and determines the value ofthe biological parameter, and reports the value including by visualdisplay and audio reporting.

The present invention can employ a cantilever for sensing system 2000,in which arm 2004 is supported rigidly at plate 2002 to carry a load,such as measuring portion 2006, said measuring portion 2006 beingdisposed along the free end 2026 of said arm 2004. The arm 2004 is fixedat a base of body 2002, with said body 2002 being a support structureexemplarily described in embodiments as a plate; a housing secured to ahead mounted gear including a headband, frame of eyewear, hats, helmets,visors, burettes for holding hair; the frame of eyewear or of a headmounted gear, clothing of any type including a shirt, a rigid structuresecured to an article of manufacturing such as apparel; and the like.The free end 2026 of arm 2004 is connected to measuring portion 2006which houses sensor 2010. Accordingly, the sensing device 2000 of theinvention has an arm 2004 that distributes force and that can applyforce to a body part. One of ways arm 2004 can be positioned and/orapply pressure to a body part is by virtue of a memory shape material ofsaid arm 2004. Any means to apply pressure to a body part can be used insensing system 2000 including a spring loaded system, in which thespring can be located at the junction 2024 of body 2002 and the arm2004, or the spring is located at the free end 2026 of arm 2004. It iscontemplated that any material with springing capabilities and any othercompressible materials and materials with spring and/or compressiblecapabilities such as foams, sponges, gels, tension rings, high-carbonspring steels, alloy spring steels, stainless steels, copper-basealloys, nickel-base alloys, and the like can be used in sensing device2000 to apply pressure for better apposition of measuring portion 2006to the body part. The invention teaches apparatus and methods forcreating better apposition and/or applying pressure to a body part orarticle by any sensor, device, detector, machine, equipment, and thelike. Sensor 2010 housed in measuring portion 2006 can therefore applypressure to a body part, such as the brain temperature tunnel area atthe roof of the orbit.

The end of arm 2004 preferably terminates as a bulging part, such asmeasuring portion 2006, which houses sensor 2010. Arm 2004 can move inrelation to plate 2002, thus allowing movement of sensor 2010 housed atthe free end 2026 of arm 2004. Although the sensing system 2000 isdescribed for a body part, it is understood that the sensing device 2000can be applied in an industrial setting or any other setting in which ameasurement of an object or article is needed. By way of illustration,sensor 2010 can include a temperature and pressure sensor while theplate 2006 is affixed to a support structure, such as a beam or wall ofa machine, and the sensor 2010 is applied against a balloon or asurface, thus providing continuous measurement of the pressure andtemperature inside the balloon or surface. Outside surface of body 2002can include an adhesive surface for securing said body 2002 to a secondsurface such as a body part or the surface of a machine or any articleof manufacturing.

In order to fit with the specialized anatomy and physical configurationof the brain tunnel, specialized sensing devices with special dimensionsand configurations are necessary. The preferred dimensions andconfigurations described herein can be applied to any embodiments ofthis invention including embodiments described from FIG. 1 to FIG. 104.The preferred configuration of sensing device 2000 comprises a body 2002that has a larger width than arm 2004. The width of body 2002 is oflarger dimension than the width of arm 2004. Preferably the width ofbody 2002 is at least twice the width of arm 2004. Most preferably, arm2004 has a width which is preferably one third or less than the width ofbody 2002. Even more preferably, arm 2004 has a width which ispreferably one fourth or less than the width of body 2002.

The sensing device 2000, as exemplarily illustrated, includes anessentially curved end portion of arm 2004 and an essentially flatremaining portion of arm 2004 said flat portion connected to body 2002.During use arm 2004 is positioned in a curved configuration to fitaround the bone of the eyebrow. Arm 2004 has two end portions, namelyend portion 2024 which terminates in body 2002 and a free end portion2026 which terminates in the measuring portion 2006. The preferredlength of arm 2004 is equal to or no greater than 15 cm, and preferablyequal to or no greater than 8 cm in length, and most preferably equal toor no greater than 5 cm in length. Depending on the size of the personother dimensions of arm 2004 are contemplated, with even more preferablelength being equal to or no greater than 4 cm, and for children lengthequal to or no greater than 3 cm, and for babies or small children thepreferred length of arm 2004 is equal to or no greater than 2 cm.Depending on the size of an animal or the support structure being usedsuch as a burette of FIG. 100R, cap of FIG. 100P, or the visor of FIG.100T other dimensions are contemplated, such as length of arm 2004 equalto or no greater than 40 cm.

The preferred width or diameter of arm 2004 is equal to or no greaterthan 6 cm, and preferably equal to or no greater than 3 cm, and mostpreferably equal to or no greater than 1.0 cm. Depending on the size ofthe person other dimensions for arm 2004 are contemplated, with an evenmore preferable width or diameter being equal to or no greater than 0.5cm, and for children width or diameter equal to or no greater than 0.3cm, and for babies or small children the preferred equal to or nogreater than 0.2 cm. Depending on the size of a large person or size ofan animal or support structure being used other dimensions for arm 2004are contemplated, such as width or diameter equal to or no greater than12 cm.

The preferred height (or thickness) of arm 2004 is equal to or nogreater than 2.5 cm, and preferably equal to or no greater than 1.0 cmin thickness, and most preferably equal to or no greater than 0.5 cm inthickness. Depending on the size of the person other dimensions for arm2004 are contemplated, with even more preferable thickness being equalto or no greater than 0.3 cm, and for children thickness equal to or nogreater than 0.2 cm, and for babies or small children the preferredthickness is equal to or no greater than 0.1 cm. Depending on the sizeof a large person or size of an animal other dimensions for arm 2004 arecontemplated, such as thickness equal to or no greater than 3.0 cm.

For devices, in which the preferred configuration of arm 2004 is acylinder, the preferred diameter of arm 2004 is equal to or no greaterthan 2.0 cm, and preferably equal to or no greater than 1.0 cm inthickness, and most preferably equal to or no greater than 0.5 cm inthickness. Depending on the size of the person other dimensions for arm2004 are contemplated, with even more preferable diameter being equal toor no greater than 0.25 cm, and most preferably being equal to or nogreater than 0.15 cm, and for children thickness equal to or no greaterthan 0.2 cm, and for babies or small children the preferred thickness isequal to or no greater than 0.1 cm. Depending on the size of a largeperson or size of an animal or the structure being used, otherdimensions for arm 2004 are contemplated, such as diameter equal to orno greater than 3.0 cm.

The preferred largest dimension of arm 2004 is equal to or no greaterthan 30 cm, and preferably equal to or no greater than 20 cm, and mostpreferably equal to or no greater than 10 cm. Preferred dimensions arebased on the size of the person or animal and structure being used suchas burette, visors, or cap. The preferred length of arm 2004 is nogreater than 40 cm, and preferably equal to or no greater than 20 cm,and most preferably equal to or no greater than 10 cm in length.Depending on the size of the person other preferred dimensions for arm2004 are contemplated, with an even more preferable length being equalto or no greater than 8 cm, and most preferably equal to or no greaterthan 6 cm, and for adults of small size length equal to or no greaterthan 5 cm, and for children length equal to or no greater than 4 cm andfor babies or small children the preferred length is equal to or nogreater than 2 cm. Arm 2004 is preferably curved at its free end 2026for fitting with the anatomy of the brain tunnel and the facial bone.

The preferred general dimensions for human use by a person of averagesize for arm 2004 are: height (or thickness or diameter) equal to orless than 0.4 cm, length equal to or less than 6 cm, and width equal toor less than 0.5 cm. The preferred height (or thickness or diameter) ofarm 2004 ranges between equal to or more than 0.1 cm and equal to orless than 0.5 cm. The preferred length of arm 2004 ranges between equalto or more than 1.0 cm and equal to or less than 8 cm. The preferredwidth of arm 2004 ranges between equal to or more than 0.1 cm and equalto or less than 1 cm.

It should be noted that for small animals such as rats, mice, chicken,birds, and other animals using the brain tunnel smaller size anddifferent configurations are contemplated.

In one embodiment the end portions of arm 2004 terminate in plate 2002and measuring portion 2006. Preferably, arm 2004 is made of a stainlesssteel type material or aluminum; however, other materials arecontemplated, including other metals, plastics, polymers, rubber, wood,ceramic, and the like. The arm 2004 should be sufficiently flexible suchthat the relative distance between sensor 2010 and a body part may beenlarged or reduced as needed in accordance to the measurement beingperformed including measurement in which sensor 2010 touches the bodypart and measurements in which sensor 2010 is spaced away from the bodypart and does not touch the body part during measurement. An exemplarysensor which does not touch a body part during measurement is athermopile. Accordingly, measuring portion 2006 can include saidthermopile or any radiation detector.

Although FIG. 86B shows arm 2004 being of different size as compared toplate 2002, it is understood that arm 2004 can have the same size ofplate 2002 or have larger size than plate 2002. The preferred largestdimension of end portion 2026 of arm 2004 is equal to or no greater than3 cm, and preferably equal to or no greater than 2 cm, and mostpreferably equal to or no greater than 1 cm. Depending on the size ofthe person, it is also contemplated that end portion 2026 has an evenmore preferable size equal to or no greater than 0.8 cm, and even mostpreferably equal to or no greater 0.6 cm. For some adults of small sizethe end portion 2026 has an even more preferable size equal to or nogreater than 0.5 cm, and for children, it is also contemplated that endportion 2026 of arm 2004 has a size equal to or no greater than 0.4 cm.and for babies the contemplated size is equal to or no greater than 0.2cm

As nanotechnology, MEMS (microelectromechanical systems), and NEMS(nanoelectromechanical systems) progresses other configurations,dimensions, and applications of the present invention are contemplated.

Although FIG. 86B shows arm 2004 being of different width (or diameter)as compared to measuring portion 2006, it is understood that arm 2004can have the same width (or diameter) of measuring portion 2006 or havea larger width (or diameter) than measuring portion 2006. Preferably thewidth (or diameter) of arm 2004 is of smaller size than the dimension(or diameter) of the measuring portion 2006. Preferably the part ofmeasuring portion 2006 connected to arm 2004 is of larger dimension thanthe width of arm 2004.

For the purpose of the description thickness and height are usedinterchangeably. The preferred configuration of sensing device 2000comprises a body 2002 (including the body of any embodiment from FIGS. 1to 104, and in particular the body corresponding to a housing orstructure securing sensors/detector described in all figures, from FIG.99A to FIG. 100Z) that is thicker than arm 2004. The height or thicknessof body 2002 is preferably of larger size than the thickness (or heightor diameter) of arm 2004. Arm 2004 has thickness (or height or diameter)which is preferably of lesser size than the thickness (or height) ofbody 2002. Arm 2004 has thickness (or height) which is preferably halfor less than the thickness (or height) of body 2002. Arm 2004 hasthickness (or height) which is most preferably one third or less thanthe thickness (or height) of body 2002.

The preferred configuration of sensing device 2000 comprises a measuringportion 2006 that is thicker than arm 2004. The measuring portion 2006preferably comprises a bulging portion which is thicker than arm 2004.Arm 2004 is thinner than measuring portion 2006. Arm 2004 has thickness(or height or diameter) which is preferably half or less than thethickness (or height or diameter) of measuring portion 2006. Arm 2004has thickness (or height or diameter) which is most preferably one thirdor less than the thickness (or height or diameter) of measuring portion2006. Even more preferably arm 2004 has thickness (or height ordiameter) which is one sixth or less than the thickness (or height ordiameter) of measuring portion 2006. It is yet contemplated that forproper functioning in accordance with the size of the user and theprinciples of the invention, measuring portion 2006 has thickness (orheight or diameter) which is 3 times or more larger than the thickness(or height or diameter) of arm 2004.

The preferred configuration of sensing device 2000 comprises an arm 2004that is longer than the height (or thickness or diameter) of measuringportion 2006. The length of arm 2004 is preferably of larger dimensionthan the largest dimension of measuring portion 2006. In the exemplaryembodiment, measuring portion 2006 is essentially cylindrical, and thusincludes a circle, said circle having a diameter. For the purposes ofthe description, an embodiment in which the circle is replaced by arectangle, square or other shape, the length of said rectangle, square,or other shape is considered an “equivalent dimension” to the diameter.Accordingly, measuring portion 2006 has diameter (or “equivalentdimension”), which is preferably half or less than the length of arm2004. Measuring portion 2006 has diameter (or “equivalent dimension”),which is preferably one third or less than the length of arm 2004. It isyet contemplated that for proper functioning in accordance with theprinciples of the invention, arm 2004 has an even more preferred length,which is 5 times or more greater than the diameter (or “equivalentdimension”) of measuring portion 2006.

The preferred configuration of sensing device 2000 comprises a measuringportion 2006, which is thicker than the body 2002, as illustrated inFIG. 86B. It is understood that in embodiments of FIG. 100A to FIG. 100Zthe body as represented by the headband and housing for electronics arecontemplated to be thicker than measuring portion 2006. The thickness(or height) of measuring portion 2006 is preferably of larger dimensionthan the thickness or height of body 2002. Body 2002 has thickness (orheight) which is preferably half or less than the thickness (or height)of measuring portion 2006. Body 2002 has thickness (or height) which ispreferably one third or less than the thickness (or height) of measuringportion 2006. It is yet contemplated that for proper functioning inaccordance with the principles of the invention, measuring portion 2006has thickness (or height) which is 4 times or more greater than thethickness (or height) of body 2002. When the embodiment includes body2002 housing a wireless transmitter and/or other electronic circuit,then body 2002 can preferably have a thickness (or height) equal to orof larger dimension than thickness (or height) of measuring portion2006.

The length of body 2002 is preferably of larger dimension than thelargest dimension of measuring portion 2006. Preferably, theconfiguration of sensing device 2000 comprises a body 2002 which has alonger length than the length of measuring portion 2006. When measuringportion 2006 includes a circular configuration, then preferably body2002 has larger length than the diameter of measuring portion 2006.Measuring portion 2006 has length (or diameter) which is preferably halfor less than the length (or diameter) of body 2002. Measuring portion2006 has length (or diameter) which is preferably one third or less thanthe length (or diameter) of body 2002. It is yet contemplated that forproper functioning in accordance to the principles of the invention,body 2002 has length (or diameter) which is 4 times or more the length(or diameter) of measuring portion 2006.

The preferred configuration of sensing device 2000 comprises an arm2004, in which the largest dimension of said arm 2004 is larger than thelargest dimension of measuring portion 2006. The preferred configurationof sensing device 2000 comprises a body 2002, in which the largestdimension of said body 2002 is larger than the largest dimension ofmeasuring portion 2006. The preferred configuration of sensing device2000 comprises an arm 2004, in which the smallest dimension of said arm2004 is equal to or smaller than the smallest dimension of measuringportion 2006. The preferred configuration of sensing device 2000comprises a body 2002, illustrated in FIG. 86B, in which the smallestdimension of said body 2002 is equal to or smaller than the smallestdimension of measuring portion 2006. The preferred configuration ofsensing device 2000 comprises an arm 2004, in which the thickness ofsaid arm 2004 has a smaller dimension than the thickness of measuringportion 2006.

It is contemplated that other geometric configurations, besides square,circle, and rectangles, can be used, such as a star, pentagon, octagon,irregular shape, or any geometric shape, and in those embodiments thelargest dimension or smallest dimension of the plate 2002 (e.g., body)of sensing device 2000 is measured against the largest dimension orsmallest dimension of the other part, such as arm 2004 or measuringportion 2006. The same apply when fabricating sensing device 2000 andthe reference is the arm 2004, but now compared to body 2000 and/ormeasuring portion 2006. Yet the same apply when fabricating sensingdevice 2000 and the reference is the measuring portion 2006, which isnow compared to body 2002 and/or arm 2004. The largest dimension of onepart is compared to the largest dimension of the other part. Thesmallest dimension of one part is compared to the smallest dimension ofthe other part.

Still in reference to FIG. 86B, the end 2024 of arm 2004 connected toplate 2002 can further include a swivel or rotating mechanism 2008,allowing rotation of arm 2004, and/or the up and down movement ofmeasuring portion 2006. The swivel or rotating mechanism 2008 caninclude a lock for locking arm 2004 in different angles. The differentangles and positions can be based on predetermined amount of pressure bysaid arm 2004 applied to a body part. In addition, arm 2004 can operateas a movable arm sliding in a groove in body 2002. According to thisarrangement, the movable arm 2004 works as a slidable shaft housing ameasuring portion 2006 in its free end. This embodiment can comprise alarger plate 2002 which is secured to the cheek or nose, and the slidingmechanism is used to position sensor 2010 of measuring portion 2006against the skin of the brain tunnel (BT) underneath the eyebrow, withbody 2002 positioned below the eye or at the eye level. This embodimentcan comprise embodiments of FIG. 90 to FIG. 100Z, including embodimentsin which the arm 2004 is secured to the forehead such as using aheadband, and the sliding mechanism is used to position sensor 2010 ofmeasuring portion 2006 against the skin of the brain tunnel (BT)underneath the eyebrow, with body of the sensing device positioned abovethe eye or at the forehead. Other embodiments are contemplated includingthe slidable mechanism and swivel mechanism used as part of a headbandand embodiments described in FIG. 99 to FIG. 100Z. Furthermore, anotherembodiment can include a dial mechanism in which the arm 2004 moves fromright to left as in the hands of a clock facing the plane of the face.In this embodiment the right brain tunnel area for example of a subjectwith a wide nose bridge can be reached by moving the dial to the 7o'clock or 8 o'clock position, said illustrative clock being observedfrom an external viewer standpoint.

Sensor 2010 at the end of measuring portion 2006 is connected toprocessing and display unit 2012 through wire 2014. Wire 2014 has threeportions 2060, 2062, 2064. Accordingly, there is seen in FIG. 86B wireportion 2060 secured to measuring portion 2006 with the free end 2066 ofsaid wire portion 2060 terminating in sensor 2010 and the opposite end2068 of said wire portion 2060 terminating in arm 2004. End 2068 of wireportion 2060 preferably terminates in a 90 degree angle between themeasuring portion 2006 and arm 2004. Second wire portion 2062 is securedto arm 2004 and terminates in body 2002 preferably in an essentially 180degree angle while the opposite end of wire 2062 forms the 90 degreeangle with wire portion 2068. In addition, in embodiments of FIG. 99 toFIG. 100Z, wire portion 2062 secured to arm 2004 may terminate in ahousing and/or printed circuit board secured for example to a headbandor any head mounted gear. Third wire portion 2064 is secured to body2002 and remains essentially flat in body 2002. Wire portion 2064terminates in reading and processing unit 2012 through a fourth wireportion 2065. Wire portion 2065 connects body 2002 to processing circuitand display 2012 which provides processing of the signal and may displaythe result. Although a 90 degree angle between measuring portion 2006and arm 2004 comprises the preferred embodiment, it is understood thatany angle including a 180 degree angle between measuring portion 2006and arm 2004 can be used. In an alternative embodiment, the axis ofmeasuring portion 2006 can be parallel to arm 2004 and body 2002, andall three wire portions 2060, 2062 and 2064 of wire 2014 can be disposedwithin the same plane of sensing device 2000. Thus wire 2014 does notneed to have the 90 degree bent for functioning in this alternativeembodiment.

Sensor 2010 at the end 2026 of arm 2004 comprises any sensor ordetector, or any element, molecule, moiety, or element capable ofmeasuring a substance or analyzing an analyte or tissue. Exemplarysensor 2010 includes electrochemical, optical, fluorescent, infrared,temperature, glucose sensor, chemical sensor, ultrasound sensing,acoustic sensing, radio sensing, photoacoustic, electrical, biochemical,opto-electronic, or a combination thereof in addition to a light sourceand detector pair, and the like, all of which for the purpose of thedescription will be referred herein as sensor 2010.

The preferred largest dimension of sensor 2010 is equal to or no greaterthan 3 cm, and preferably equal to or no greater than 1.5 cm, and mostpreferably equal to or no greater than 0.5 cm. Preferred dimensions arebased on the size of the person or animal. Depending on the size of theperson other dimensions of sensor 2010 are contemplated, such as largestdimension equal to or no greater than 0.3 cm, and for adults of smallsize dimension equal to or no greater than 0.2 cm, and for smallchildren dimension equal to or no greater than 0.1 cm and for babiespreferred dimension is equal to or no greater than 0.05 cm. If more thanone sensor is used the dimensions are larger, and if a molecule ormoiety are used as sensing element the dimensions are very small andmuch smaller than any of the above dimensions.

When sensor 2010 comprises a temperature sensor the preferred largestdimension of the sensor is equal to or less than 5 mm, and preferablyequal to or less than 4 mm, and most preferably equal to or less than 3mm, and even more preferably equal to or less than 2 mm. When thetemperature sensor has a rectangular configuration, a preferred width isequal to or less than 1 mm, and preferably equal to or less than 500microns. Those specialized small dimensions are necessary for properfitting of the sensor with the thermal structure of the tunnel and theentry point of the BTT.

Sensor 2010 can also comprise a radiation source and radiation detectorpair, such as a reflectance measuring system, a transmission measuringsystem, and/or an optoelectronic sensor. Preferably the distance fromthe outer edge of radiation source (e.g. light emitter) to the outeredge of detector is equal to or less than 3.5 cm, and more preferablyequal to or less than 2.0 cm, and most preferably equal to or less than1.7 cm, and even most preferably equal to or less than 1.2 cm.

In one embodiment sensor system 2010 can further comprise a temperaturesensor and include a heating or a cooling element. It is understood thata variety of sensing systems such as optical sensing, fluorescentsensing, electrical sensing, electrochemical sensing, chemical sensing,enzymatic sensing and the like can be housed at the end of arm 2004 orin measuring portion 2006 in accordance to the present invention.Exemplarily, but not by way of limitation, an analyte sensing systemsuch as a glucose sensing system and/or a pulse oximetry sensorcomprised of light emitter (also referred to as light source) and lightdetector can be housed at the end of arm 2004 and operate as sensorsystem 2010. Likewise a combination light emitter and photodetectordiametrically opposed and housed at the end of arm 2004 to detect oxygensaturation, glucose levels, or cholesterol levels by optical means andthe like can be used and are within the scope of the present invention.Furthermore, a radiation detector can be housed at the end of arm 2004for detecting radiation emitted naturally from the brain tunnel and/orthe skin area at the brain tunnel between the eye and the eyebrow or atthe roof of the orbit.

Sensor 2010 can be a contact or non-contact sensor. In the embodimentpertaining to a contact sensor, exemplarily illustrated as a thermistor,then arm 2004 is positioned in a manner such that sensor 2010 is layingagainst the skin at the BTT and touching the skin during measurement.When a non-contact sensor is used, two embodiments are disclosed:

Embodiment No. 1 Measuring portion 2006 is spaced away from the skin anddoes not touch the skin, and both measuring portion 2006 and sensor 2010housed in the measuring portion 2006 do not touch the skin duringmeasurement. This embodiment is exemplarily illustrated as an infrareddetector. This infrared detector is adapted for receiving infraredradiation naturally emitted form the brain tunnel, between the eye andthe eyebrow. Exemplarily infrared radiation emitted includesnear-infrared radiation, mid-infrared radiation, and far-infraredradiation. The emitted infrared can contain spectral information and/orradiation signature of analytes, said infrared radiation signature beingused for noninvasive measurement of analytes, such as glucose.Alternatively, infrared radiation source, including but not limited to,near-infrared or mid-infrared can be used and the near infraredradiation and/or mid-infrared radiation directed at the brain tunnelgenerates a reflected radiation from the brain tunnel, which is used fornon-invasive measurement of an analyte. In addition, any emittedelectromagnetic radiation can contain spectral information and/orradiation signature of analytes, said infrared radiation signature beingused for noninvasive measurement of analytes, such as glucose, oranalyze of tissue.

Embodiment No. 2 Sensor 2010 does not touch the skin but walls of ameasuring portion 2006, which houses the sensor 2010, touch the skin. Inthis embodiment, there is a gap or space inside measuring portion 2006and the skin at the BTT, allowing thus the sensor 2010, which is spacedaway from the skin, not to be exposed to air or ambient temperaturewhile still not touching the skin. Accordingly, the sensor 2010 ishoused in a confined environment formed by essentially the walls of twostructures: the wall of the measuring portion 2006 and the wall formedby the skin at the BTT. This embodiment is exemplarily illustrated as aninfrared detector. This infrared detector is adapted for receivinginfrared radiation naturally emitted form the brain tunnel. Exemplarilyinfrared radiation emitted includes near-infrared radiation,mid-infrared radiation, and far-infrared radiation. The emitted infraredcan contain the radiation signature of analytes, said infrared radiationsignature being used for noninvasive measurement of analytes, such asfor example glucose, cholesterol, or ethanol. Alternatively, an infraredradiation source such as near-infrared, mid-infrared, and far-infraredin addition to fluorescent light can be used with said radiationdirected at the brain tunnel, which generates a reflected radiation fromthe brain tunnel, with said reflected radiation containing a radiationsignature of an analyte and being used for non-invasive measurement ofan analyte. In addition, any source of electromagnetic radiation, anysound generating device, and the like can be housed in a measuringportion.

Sensor 2010 can be covered with epoxi, metal sheet, or other material,and in those embodiments the dimensions in accordance with the inventionare the dimension of the material covering sensor 2010.

The preferred largest dimensions for body 2002, illustrativelyrepresented by a rectangular plate in FIG. 86B, is equal to or nogreater than 18 cm, and preferably equal to or no greater than 10 cm,and most preferably equal to or no greater than 6 cm. The preferreddimensions for plate 2002 for human use are equal to or less than 8 cmin length, equal to or less than 6 cm in width, and equal to or lessthan 2 cm in thickness. The most preferred dimensions for plate 2002 forhuman use are equal to or less than 6 cm in length, equal to or lessthan 4 cm in width, and equal to or less than 1 cm in thickness. Mostpreferably, the dimensions for plate 2002 are equal to or less than 4 cmin length, equal to or less than 2 cm in width, and equal to or lessthan 0.5 cm in thickness. Although plate 2002 is shown in a rectangularshape, any other shape or configuration can be used including circular,oval, square, oblong, irregular, and the like. It is also contemplatedthat dimensions of a housing, such as a box, as described for a headbandand in the embodiments of FIGS. 99 to 100Z may have differentdimensions. For those embodiments the electronics can be spread alongthe headband making it very thin. Alternatively if a large number ofcomponents is used including Bluetooth transmitters, which are commonlyof larger size, larger dimensions are contemplated.

It is understood that plate 2002 can preferably house electronics,microchips, wires, circuits, memory, processors, wireless transmittingsystems, light source, buzzer, vibrator, accelerometer, LED, and anyother hardware and power source necessary to perform functions accordingto the present invention. It is also understood that arm 2004 can alsohouse the same hardware as does plate 2002, and preferably houses a LEDor lights that are within the field of view of the user, so as to alertthe user when necessary. Sensing device 2000 can be powered by a powersource housed in the plate 2002. It is understood that sensing device2000 can be powered by an external power source and that wire 2014 canbe connected to said external power source. The external power sourcecan preferably include processing circuit and display.

It is also understood that any support structure, head mounted gear,frame of eyeglasses, headband, and the like can be employed as body2002, or be coupled to measuring portion 2006, or be connected to arm2004. When arm 2004 and its sensor 2010 at the end of said arm 2004 iscoupled to another support structure, such as frame of eyeglasses,helmet, and the like, the frame of said eyeglasses or said helmetoperates as the body 2002, and it is used as the connecting point forarm 2004.

Now in reference to FIG. 86C, the measuring portion 2006, as exemplarilyillustrated in FIG. 86C, comprises an essentially cylindrical shape.Measuring portion 2006 preferably comprises a body 2020 and a connectingportion 2011, which connects measuring portion 2006 to arm 2004. Body2020 has preferably two end portions, namely top end 2016 and a bottomend 2018, said top end 2016 being connected with connecting portion 2011and arm 2004 and said bottom end 2018 housing sensor 2010. The body 2020houses wire 2060 for connecting sensor 2010 to a transmitting and/orprocessing circuit and/or display (not shown). In an embodiment formeasuring temperature body 2020 includes a soft portion 2009 which ispreferably made with insulating material and said body 2020 hasinsulating properties. The bottom end 2018 has insulating properties andis void of heat conducting elements such as metal, heat conductingceramic, and heat conducting gel, heat conducting polymers, and thelike. Contrary to the prior art which uses heat conductive material toencapsulate around a temperature sensor in order to increase heattransfer from the article or body being measured, the probe of thisinvention is void of heat conductive materials.

Body 2020 and connecting portion 2011 can also house electronics, chips,and/or processing circuits. In one embodiment body 2020 includes a softportion and connecting portion 2011 comprises a hard portion.

For temperature measurement and for monitoring certain biologicalparameters, measuring portion 2006 preferably includes a non-metallicbody 2020, said non-metallic body housing wire portion 2060. In oneembodiment for measuring temperature sensor 2010 comprises a temperaturesensor and body 2020 preferably comprises insulating material, saidinsulating material preferably being a soft material and havingcompressible characteristics. Although compressible characteristics arepreferred, it is understood that body 2020 can also comprise rigidcharacteristics or a combination of rigid and soft portions. Mostpreferably body 2020 comprises a combination of a rigid part and a softpart, said soft part being located at the free end of body 2020, andwhich is in contact with a body part, such as of a mammal.

In one embodiment sensor 2010 comprises a pressure sensor orpiezoelectric element and operates as a pulse and/or pressure measuringportion. In another embodiment sensor 2010 comprises an electrochemicalsensor for measurement of analytes such as glucose. In anotherembodiment sensor 2010 comprises an ultrasound sensing system. Inanother embodiment sensor 2010 comprises a photoacoustic sensing systemfor measurement of chemical substances such as glucose. In anotherembodiment, sensor 2010 comprises a fluorescent element or fluoresceinmolecule for evaluating temperature, pressure, pulse, and chemicalsubstances including analytes such as glucose. In another embodiment,sensor 2010 comprises an infrared detector for measuring temperatureand/or concentration of chemical substances in blood from radiationnaturally emitted from the brain tunnel.

The preferred diameter of measuring portion 2006, illustrated as thediameter of the body 2020, housing a temperature sensor is equal to orno greater than 4 cm, and preferably equal to or no greater than 3 cm,and most preferably equal to or no greater than 2 cm. Depending on thesize of the person other even more preferable dimensions for measuringportion 2006 are contemplated, such as diameter equal to or no greaterthan 1.2 cm, and much more preferably equal to or less than 0.8 cm. Forchildren preferred diameter is equal to or no greater than 0.6 cm, andfor babies or small children the preferred diameter is no greater than0.4 cm. Depending on the size of an animal or person other dimensionsfor measuring portion 2006 are contemplated, such as diameter equal toor no greater than 5 cm.

When a cylindrical shape is used, the preferred diameter of measuringportion 2006 for chemical or certain physical measurement is no greaterthan 4 cm, and preferably no greater than 3 cm, and most preferably nogreater than 2 cm. The same dimensions apply to a non-cylindrical shape,such as a rectangle, and the preferred length of the rectangle is nogreater than 4 cm, and preferably no greater than 3 cm, and mostpreferably no greater than 2 cm. Depending on the size of the personother even more preferable dimensions for measuring portion 2006 arecontemplated, such as a diameter equal to or no greater than 1.2 cm, andmuch more preferably equal to or no greater than 0.8 cm. For children apreferred diameter is equal to or no greater than 0.7 cm, and for babiesor small children the preferred diameter is equal to or no greater than0.5 cm. Depending on the size of an animal or person other dimensionsfor measuring portion 2006 are contemplated, such as diameter equal toor no greater than 6 cm.

When a non-cylindrical shape is used, such as a rectangle, the preferredwidth of measuring portion 2006 is equal to or no greater than 2 cm, andpreferably equal to or no greater than 1.5 cm, and most preferably equalto or no greater than 1 cm. Depending on the size of the person otherdimensions for measuring portion 2006 are contemplated, such as widthequal to or no greater than 0.8 cm and more preferably equal to or nogreater than 0.5 cm, and for children width equal to or no greater than0.4 cm, and for babies or small children the preferred width is equal toor no greater than 0.3 cm. Depending on the size of an animal or personother dimensions for measuring portion 2006 are contemplated, such aswidth equal to or no greater than 5 cm.

The preferred height (or thickness) of measuring portion 2006,considering a cylindrical shape, is equal to or no greater than 4 cm,and preferably equal to or no greater than 2.0 cm in thickness (orheight), and most preferably equal to or no greater than 1.5 cm inthickness (or height), and much more preferably equal to or no greaterthan 1.3 cm. Depending on the size of the person other dimensions ofmeasuring portion 2006 are contemplated, such as height (or thickness)equal to or no greater than 1.0 cm, and for children thickness (orheight), equal to or no greater than 0.8 cm, and for babies or smallchildren equal to or no greater than 0.5 cm. Depending on the size of ananimal other dimensions of measuring portion 2006 are contemplated, suchas thickness (or height) equal to or no greater than 5 cm. In the caseof a measuring portion having a rectangular shape, the thickness orheight referred to herein, is replaced by the length of the rectangle,and the above dimensions then are applicable.

The following preferred dimensions in this paragraph pertain to a singlesensor, such as a temperature sensor or a pulse sensor or a chemicalsensor. In this embodiment the preferred largest dimension of measuringportion 2006 is equal to or no greater than 6 cm, and preferably equalto or no greater than 3 cm, and most preferably equal to or no greaterthan 1.5 cm. The preferred general dimensions for human use formeasuring portion 2006 having a cylindrical shape are height (orthickness) equal to or less than 1.2 cm and diameter equal to or lessthan 0.8 cm, and most preferably height equal to or less than 1.0 cm anddiameter equal to or less than 0.6 cm Preferred length of anon-cylindrical measuring portion 2006 is equal to or less than 1.2 cmand width equal to or less than 0.8 cm, and most preferably length equalto or less than 1.0 cm and width equal to or less than 0.6 cm. Thepreferred height (or thickness) of measuring portion 2006 ranges betweenequal to or more than 0.4 cm and equal to or less than 2.0 cm. Thepreferred diameter of measuring portion 2006 ranges between equal to ormore than 0.4 cm and equal to or less than 2.0 cm. Although atemperature sensor was illustrated, it is understood that any sensor canbe used. For a pair sensor-detector, a pair light emitter-detector, aninfrared sensor, or a sensor and combination with other elements such asa heating element other dimensions can be preferably used, and will bedescribed below.

Measuring portion 2006 can be formed integral with arm 2004 creating asingle part consisting of an arm and a measuring portion. Preferably, atleast a portion of the material used for measuring portion 2006 isdifferent from the material used for arm 2004. Arm 2004 and measuringportion 2006 preferably comprise two separate parts. In one embodimentfor measuring temperature the arm 2004 is made in its majority with anadjustably positionable material such as deformable metal whilemeasuring portion 2006 includes a portion of non-metal materials such aspolymers, plastics, and/or compressible materials. The metal portion ofarm 2004 can be preferably covered with rubber for comfort. Preferredmaterials for measuring portion 2006 include foams, rubber,polypropylene, polyurethane, plastics, polymers of all kinds, and thelike. Preferably, measuring portion 2006 housing a temperature sensorcomprises an insulating material, and includes a compressible materialand/or a soft material. Measuring portion 2006 can include anycompressible material. Measuring portion 2006 can further include aspring housed in the body 2020. Any other material with springcapabilities can be housed in body 2020 of measuring portion 2006.

Preferably, the end portion 2018 of measuring portion 2006 comprises aninsulating material. Preferably the end portion 2018 comprises anon-heat conducting material including non-metallic material ornon-metal material. Preferably, the end portion 2018 comprises a softmaterial including polymers such as polyurethane, polypropylene,Thinsulate, and the like in addition to foam, sponge, rubber, and thelike.

The largest dimension of end portion 2018 of measuring portion 2006 ispreferably equal to or less than 4 cm, and most preferably equal to orless than 2 cm, and even more preferably equal to or less than 1.5 cm.Accordingly, the dimensions of sensor 2010 preferably follow thosedimensions of end portion 2018, said sensor 2010 being of smallerdimension than the dimension of end portion 2018. For the embodiment formeasurement of temperature, the largest dimension of end portion 2018 ispreferably equal to or less than 1 cm, and most preferably equal to orless than 0.8 cm, and even most preferably equal to or less than 0.6 cm.

Methods and apparatus include measuring portion 2006 touching the bodypart during measurements or measuring portion 2006 being spaced awayfrom the body part and not touching the body during measurement.

In one preferred embodiment the end portion 2018 of measuring portion2006 does not have an adhesive surface and the surface around sensor2010 is also adhesive free. In the prior art, sensors are secured inplace by adhesive surfaces, with said adhesive surrounding the sensor.Contrary to the prior art, sensors of the present invention do not haveadhesive surrounding said sensors, and said sensors of the presentinvention are secured in place at the measuring site in the body of amammal by another structure, such as arm 2004, with the adhesive surfacebeing located away from the sensor surface. Accordingly, in onepreferred embodiment of the present invention, the surface of the sensorand the surface of the surrounding material around the sensor isadhesive free.

Now in reference to FIG. 86D, by way of an example, FIG. 86D shows aplanar diagrammatic view of an embodiment that includes a body 2002-ashaped as a square, an arm 2004-a shaped in a zig-zag configuration anda measuring portion 2006-a shape as a hexagon. In this embodiment, theheight (or thickness) of the measuring portion 2006 (represented hereinby the height or thickness of the hexagon 2006-a) is of larger dimensionthan the height or thickness of the arm 2004 (represented herein by thethickness of the zig-zag arm 2004-a). The thickness of square body2002-a is the smallest dimension of said square body 2002-a, which iscompared to the smallest dimension of the hexagon 2006-a, which is thelength of said hexagon 2006-a from point (a) to (b). Accordingly,thickness of the square 2002-a (body) is smaller than the length ofhexagon 2006-a, said hexagon 2006-a representing a measuring portion.The length of arm 2004-a is the largest dimension of arm 2004-a, whichis compared to the largest dimension of hexagon 2006-a, which is theheight or thickness of said hexagon 2006-a, from point (c) to point (d),as seen in FIG. 86E.

FIG. 86E is a diagrammatic side view of the embodiment of FIG. 86D andillustrates the thickness (or height) of the embodiment of FIG. 86D.Accordingly, as per the principles of the invention, length of thezig-zag arm 2004-a, represented by point (e) to (f), is of greaterdimension than the thickness of hexagon 2006-a, represented by point (c)to (d).

To further illustrate the principles of the invention, FIG. 86F shows anembodiment that includes a body 2002-b shaped as an irregular geometricshape, an arm 2004-b shaped in a triangular configuration and ameasuring portion 2006-b shape as a rectangle. The thickness of arm2004-b is the smallest dimension of arm 2004-b, which is compared to thesmallest dimension of rectangle 2006-b, which is the width of saidrectangle 2006-b from point (g) to point (h). Accordingly, as per theprinciples of the invention, the thickness of the arm 2004-b is equal toor smaller than the width of rectangle 2006-b, with said rectangle2006-b representing a measuring portion.

FIG. 86G is a diagrammatic perspective view of another preferredembodiment showing end portion 2018 of measuring portion 2006 having alight emitter-light detector pair assembly 2030, also referred to asradiation source-radiation detector pair. The end portion 2018 ofmeasuring portion 2006 in this embodiment has preferably a largerdimension than the diameter (or dimension) of body 2020 of saidmeasuring portion 2006. The radiation source-detector pair 2030 ispreferably housed in a substantially rigid substrate 2024, such as aplastic plate. Although substrate 2024 can have any shape, exemplarilyand preferably substrate 2024 has an essentially rectangular shape.Rectangular plate 2024 houses at least one light emitter 2032 in oneside and at least one light detector 2034 on the opposite side. Lightemitter 2032 is connected to at least one wire 2036 secured to the body2020 of measuring portion 2006. Detector 2034 is connected to at leastone wire 2038 secured to the body 2020 of measuring portion 2006. Wire2036, 2038 start at the light-emitter-light detector pair 2030 in plate2024 and run along the body 2020. Wire 2036 and wire 2038 preferablyform a single multi-strand wire 2040 which exit body 2020 at the upperportion 2016 of measuring portion 2006, said wire 2040 being disposed onor within arm 2004, and further disposed on or within body 2002 forconnecting light emitter-detector pair assembly 2030 to a processingcircuit and display and/or a transmitter 2031. The body 2020 ofmeasuring portion 2006 can preferably comprise a rigid material. Thelight emitter 2032 and detector 2034 are centrically located in plate2024 in this illustrative embodiment. It is understood that lightemitter 2032 and detector 2034 can be eccentrically located in plate2024 depending on the anatomic configuration of the subject beingmeasured.

FIG. 86H is a diagrammatic cross-sectional view of a preferredembodiment, and depicts a sensing device 2000 including body 2020 ofmeasuring portion 2006 having on its free end the light source-lightdetector pair 2030, with light detector 2034 being adjacent to lightsource 2032. The radiation source-detector pair assembly 2030 ispreferably mounted on a substantially rigid holder, such as plate 2024.Plate 2024 can preferably comprise a rigid or semi rigid material toallow stable reflectance measurements. Detector 2034 includes aphotodetector adapted to detected radiation, including infraredradiation, received from light source 2032 and can include a printedcircuit board. Light source assembly 2032 is adapted to emit radiation,including infrared radiation, directed at the brain tunnel and caninclude a printed circuit board. Plate 2024 can house a single or aplurality of light sources and a single or a plurality of lightdetectors. For example, in a pulse oximetry sensor the light sourceassembly may include a plurality of light sources, such as a red lightemitting diode and an infrared light emitting diode. Illustrativelyplate 2024 is shown housing one light source 2032 in one side and onedetector 2034 on the opposite side. Light emitter 2032 is connected toat least one wire 2036 secure to the body 2020 of measuring portion2006. Detector 2034 is connected to at least one wire 2038 secured tothe body 2020 of measuring portion 2006. Body 2020 is shown as anintegral part with arm 2004. In this embodiment body 2020 of measuringportion 2006 forms one piece with arm 2004. Wires 2036, 2038 start atthe light source-light detector pair assembly 2030 in plate 2024 and runon or within the body 2020. Wire 2036 and wire 2038 preferably form asingle multi-strand wire 2040 which exits body 2020 and runs along arm2004, and is further disposed on or within body 2002. Electric signalsare carried to and from the light source and light detector assembly2030 preferably by the multi-strand electric cable 2040, whichterminates at an electrical connector for connection to a processingcircuit and display and/or a transmitter (not shown). Wires 2036, 2038,and 2040 can be disposed on or within the measuring portion 2006, arm2004, or body 2002. Plate 2024 can preferably be adapted to provideprotection against light from the environment reaching emitter-detectorpair 2030.

FIG. 86-I is a planar bottom view of plate 2024 showing an exemplaryembodiment of said plate 2024. Plate 2024 has preferably two openings2035, 2033 for respectively housing light emitter 2032 and lightdetector 2034. Light emitter 2032 and light detector 2034 are preferablydisposed adjacent to each other, and in the center of plate 2024. Thelight source 2032 and light detector 2034 may be encased by a protectivetransparent material such as silicone.

Although the preferred embodiment includes an arm 2004 for supportstructure which works as a sensing device 2000, it is understood thatarm 2004 can be replaced by a wire or cord. Accordingly, FIG. 86J showsa diagrammatic planar view of an alternative embodiment comprising anadhesive patch 2025 securing plate 2024, said adhesive patch beingconnected through cord 2041 to a reading and display unit 2043. Themeasuring portion in this embodiment comprises an adhesive patch housinga sensor assembly, said adhesive patch connected through a cord to adisplay unit. Illustratively the sensor or sensing portion in thisembodiment is represented by light source-light detector pair 2030.Plate 2024 includes emitter 2032 and detector 2034, respectivelyconnected to wire 2036 and wire 2038. Wire 2036 and 2038 terminates incord 2041. Cord 2041 houses the wires 2036, 2038, and is preferablyflexible in nature. In order to fit the tunnel, and in accordance withthe present invention specialized dimensions are needed for functioning.The preferred longest distance between the edge of plate 2024 andadhesive patch 2025 is equal to or less than 12 mm, and preferably equalto or less than 6 mm, and most preferably equal to or less than 3 mm.The largest dimension of patch 2025 is preferably equal to or less than3 cm and most preferably equal to or less than 2 cm, and even mostpreferably equal to or less than 1.5 cm. Preferably plate 2024 islocated in an eccentric position on adhesive patch 2025.

FIG. 86J shows by way of illustration edge 2023 of plate 2024 and edge2027 of patch 2025, both located at the free end of the patch 2025opposite to the cord 2041. Edge 2023 is located preferably equal to orless than 8 mm from the edge 2027 of adhesive patch 2025, and mostpreferably equal to or less than 5 mm from edge 2027 of adhesive patch2025, and even more preferably equal to or less than 3 mm from edge 2027of adhesive patch 2025. Preferred dimensions of the plate 2024 aredescribed in FIG. 86N. A preferred dimension of adhesive patch 2025includes a width or diameter equal to or less than 25 mm, and preferablyequal to or less than 20 mm, and most preferably equal to or less than15 mm, and even more preferably equal to or less than 10 mm. Thosedimensions are preferably used for a centrically placed single sensor,multiple sensors, light emitter-light detector pair, or for aneccentrically placed sensor. The preferred configuration of the adhesivepatch is rectangular or oblong, or any configuration in which the sidesof the geometric figure are not equal in size. In this embodiment thereis no body for the support structure as in the embodiments of FIG. 86Hand FIG. 86G. The support structure in this embodiment is comprised of aspecialized adhesive patch 2025 connected to a cord 2041, said cord 2041terminating in a processing circuit and display unit 2043. It is alsocontemplated that cord 2041 can exit patch 2025 from any of its sides

FIG. 86K shows another embodiment when worn by a user comprised of anadhesive patch 2060 housing a light emitter-light detector pair 2062,which is housed in a holder such as plate 2064, said plate 2064 beingadjacent to the edge of said adhesive patch 2060. At least one portionof adhesive patch 2060 and the light emitter-light detector pair 2062 islocated between the eyebrow 2066 and eye 2068. At least a sensor such aslight emitter-light detector pair 2062 is located between the eye 2066and the eyebrow 2068. Adhesive patch 2062 can include a forehead portion2070 located on the forehead and an upper eyelid portion 2072 located onthe upper eyelid. Any sensor including a pair light emitter-lightdetector is preferably positioned adjacent to the junction 2074, saidjunction representing a junction of the end of the eyebrow 2066 with theupper portion of the nose 2075, said junction 2074 represented as a darkcircle in FIG. 86K. A sensor housed in the adhesive patch is preferablylocated in the roof of the orbit area, right below the eyebrow. Adhesivepatch 2060 further includes wire 2076 which terminates in a processingcircuit and display unit 2078.

FIG. 86L shows another embodiment when worn by a user comprised of anadhesive patch 2080 housing light emitter-light detector pair 2082, saidemitter and detector 2082 being located apart from each other, andadjacent to edge 2084 of said adhesive patch 2080. At least one portionof adhesive patch 2080 and a sensor such as the light emitter-lightdetector pair 2082 is located between the eyebrow 2086 and eye 2088. Atleast light emitter-light detector pair 2082 is located between the eye2086 and the eyebrow 2088. Adhesive patch 2080 comprises a nose portion2090 located on the nose and an upper eyelid portion 2092. Any sensorincluding a pair light emitter-light detector is preferably positionedadjacent to the eyebrow 2086. The sensor housed in the adhesive patch ispreferably located above the eye 2088 and just below the eyebrow 2086.Adhesive patch 2080 further includes wire 2094 which terminates in aprocessing circuit and display unit 2096, which processes the signal ina conventional manner to detect oxygen saturation and/or concentrationof analytes.

FIG. 86M shows another embodiment comprised of a clover-leaf adhesivepatch 2100 housing light emitter-light detector pair 2102 housed inplate 2104, and preferably adjacent to edge 2106 of said adhesive patch2100. Adhesive patch 2100 comprises a sensing portion 2108 housing plate2104 and a supporting portion 2110 that includes an adhesive surface.Emitter-detector pair 2102 is preferably eccentrically positioned onpatch 2100 and further includes wire 2113 from light emitter 2114 andwire 2116 from detector 2118. Wires 2113 and 2116 join at the edge ofplate 2104 to form cord 2112 which terminates in unit 2120 which housesprocessing circuit 2124, memory 2126, and display 2122.

Light emitter 2114 preferably emits at least one infrared wavelength anda detector 2118 is adapted to receive and detect at least one infraredwavelength. Light emitter-detector pair 2102 is preferably eccentricallypositioned in adhesive patch 2100, said light emitter-detector pair 2102being located at the edge of patch 2100. Imaginary line from point (A)to point B going across plate 2104 on adhesive patch 2100 housing lightemitter-detector pair 2102 measures equal to or less than 3.0 cm, andpreferably measures equal to or less than 2.0 cm, and most preferablyequal to or less than 1.5 cm. The preferred distance of external edge2103 of light emitter-detector pair 2102 to the edge 2105 of patch 2100is less than 14 mm, and preferably less than 10 mm and most preferablyless than 5 mm.

Another embodiment includes an adhesive patch housing a sensor comprisedof an adhesive surface intersected by a non-adhesive surface.Accordingly, FIG. 86M(1) shows the back side of adhesive patch 2131,said side being disposed toward the skin and in contact with the skin,and comprised of a first adhesive surface 2121, a second non-adhesivesurface 2123, and a third adhesive surface 2125 which houses the sensor2127. The adhesive surface is intersected by a non-adhesive surface. Thenon-adhesive surface 2123 is adapted to go over the eyebrow, preventingthe adhesive from attaching to hair of the eyebrow.

FIG. 86N is another embodiment showing the configuration and dimensionsof light emitter-detector pair 2130 and plate 2136. Light emitter 2132and detector 2134 are disposed preferably as a pair and are positionedside-by-side for reflectance measurements. The preferred dimension oflight emitter 2132 is no greater than 1.5 cm in its largest dimensionand preferably no greater than 0.7 cm, and most preferably no greaterthan 0.5 cm, and even most preferably equal to or less than 0.4 cm. Thepreferred dimension of detector 2034 is equal to or no greater than 1.5cm in its largest dimension and preferably equal to or no greater than0.7 cm, and most preferably equal to and no greater than 0.5 cm, andeven most preferably equal to or less than 0.4 cm. The preferreddistance between inner edge 2138 of light emitter 2132 and the inneredge 2140 of detector 2134 is equal to or less than 0.7 cm, andpreferably equal to or no greater than 0.5 cm, and most preferably equalto or no greater than 0.25 cm. It is understood that to better fit theanatomic configuration of the brain tunnel for a vast part of thepopulation, light emitter 2132 and detector 2134 are preferably disposedside-by-side and the distance between the inner edge 2138 of lightemitter 2132 and inner edge 2140 of detector 2134 is preferably equal toor no greater than 0.1 cm.

Although a pair radiation emitter-detector has been described, it isunderstood that another embodiment includes only a radiation detectorand the measuring portion 2006 is comprised of a radiation detector fordetecting radiation naturally emitted by the brain tunnel. Thisembodiment can include a infrared detector and is suitable fornon-invasive measurement of analytes including glucose as well astemperature, with detector adapted to contact the skin or adapted asnon-contact detectors, not contacting skin during measurement.

FIG. 86P shows another embodiment comprised of an essentiallycylindrical measuring and sensing portion 2150. Cylindrical structure2150 operates as the measuring portion and houses a emitter-detectorpair 2152 and a wire portion 2153, with said measuring portion 2150being connected to arm 2154. Arm 2154 comprises an adjustablypositionable arm which houses wire portion 2155. Arm 2154 is preferablycylindrical contrary to arm 2004 which has preferably a flatconfiguration. Arm 2154 connects measuring portion 2150 to supportingportion 2151 which includes adhesive and/or attachment means. Lightemitter 2156 and light detector 2158 are preferably positioned adjacentto each other within the holder 2150, represented by cone structure.Light emitter-detector pair 2152 can preferably have a bulging portion,which goes beyond the plane of the edge 2162 of cylindrical measuringportion 2150. Cylindrical measuring portion 2150 can also include aspring 2160, or any other compressible material or material withspring-like characteristics, said spring 2160 or compressible materialbeing disposed along wire portion 2153. Light emitter-detector pair 2152is disposed at the free end of said spring 2160. It is understood thatany sensor, molecule, detector, chemical sensors, and the like can bedisposed at the free end of spring 2160. Wire portion 2155 terminates inwire portion 2149 disposed on or within body 2151. Body 2151 can includeany support structure, preferably a plate such as shown in FIG. 86A, aswell as the frame of eyewear, a headband, the structure of a helmet, thestructure of a hat, or any head mounted gear. Wire 2149 can be furtherconnected to a processing circuit and display 2147.

Preferred diameter at the free end of measuring portion 2150 is equal toor no greater than 3.5 cm, and preferably equal to or no greater than2.0 cm, and most preferably equal to or no greater than 1.5 cm, and evenmost preferably equal to or no greater than 1.0 cm. Depending on size ofa subject and the type of sensor such as temperature, pressure, and thelike the preferred diameter at the free end of measuring portion 2150 isequal to or no greater than 0.8 cm and preferably equal to or no greaterthan 0.6 cm, and more preferably equal to or no greater than 0.4 cm.Preferred length from point 2150(a) to point 2150(b) of measuringportion 2150 is equal to or no greater than 3 cm, and preferably equalto or no greater than 1.5 cm, and most preferably equal to or no greaterthan 1 cm. Depending on size of a subject the preferred length frompoint 2150(a) to point 2150(b) of cone structure 2150 is equal to or nogreater than 0.8 cm and preferably equal to or no greater than 0.6 cm,and more preferably equal to or no greater than 0.4 cm. Measuringportion 2150 can include a contact sensor in which the sensor contactsthe skin at the brain tunnel or a non-contact sensor in which the sensordoes not contact the skin at the brain tunnel during measurement.

FIG. 86P(1) is an exemplary sensing device 2191 for non-contactmeasurements at the brain tunnel 2187 and shows sensing portion 2181housing a sensor illustrated as an infrared sensor 2183 to detectinfrared radiation 2185 coming from the brain tunnel 2187. Sensingportion 2181 housing sensor 2183 is connected to body 2193 throughadjustably positionable arm 2189. Wire 2195 connects sensor 2183 to body2193. Sensor 2183 can include any infrared detector, and is adapted toreceive and detect infrared radiation from the brain tunnel 2187 fordetermining temperature, concentration of substances including glucose,and any other measurement of analytes or tissue. Sensor 2183 can alsowork as a fluorescent sensor, and may include a fluorescent light sourceor fluorescein molecules. Furthermore, sensor 2183 can include enzymaticsensors or optical sensors.

FIG. 86P(2) is an exemplary sensing device 2197 for non-contactmeasurements at the brain tunnel 2187 and shows sensing portion 2199housing a light source-light detector pair assembly 2201, such as aninfrared sensor or a fluorescent element. It is contemplated that anyelectromagnetic radiation including radio waves can be directed at thebrain tunnel for determining concentration of analytes and/or presenceof analytes and/or absence of analytes and/or evaluating tissue. Lightsource 2203 directs radiation 2207 such as mid-infrared and/ornear-infrared radiation at the brain tunnel 2187 which containsmolecules 2205 (including analytes such as glucose), said radiation 2207generating a reflected radiation that contains the radiation signatureof the analyte being measured after said radiation 2207 interacts withthe analyte being measured. The reflected radiation 2209 is thendetected by detector 2211. The electrical signal generated by thedetector 2211 is then fed to a processing circuit (not shown) housed inbody 2217 through wire 2213 housed in arm 2215. Sensing portion 2199housing pair assembly 2201 is preferably connected to body 2217 throughan adjustably positionable arm. Detector 2211 can include any infrareddetector, and is adapted to receive and detect infrared radiation fromthe brain tunnel 2187 for determining temperature, concentration ofsubstances including glucose, and any other measurement of analytes ortissue. Detector 2211 can also work as a fluorescent detector fordetecting fluorescent light generated.

FIG. 86P(3) is an exemplary hand-held sensing device 2219 fornon-contact measurements at the brain tunnel 2187 and shows a lightsource-light detector pair assembly 2221. Light source 2223 directsradiation 2225 at the brain tunnel 2187 which contains molecules 2205(including analytes such as glucose), said radiation 2225 generating areflected radiation 2227 that contains the radiation signature of theanalyte being measured after said radiation 2225 interacts with theanalyte being measured. The reflected radiation 2227 is then detected bydetector 2231. The electrical signal generated by the detector 2231 isthen fed to a processing circuit 2233 which calculates the concentrationof an analyte based on a calibration reference stored in memory 2235,and display said concentration on display 2237. It is understood thatinstead of a pair light source-light detector, a stand alone detectorfor detecting infrared radiation naturally emitted from the brain tunnelcan also be used. It is also understood that sensing device 2219 canpreferably include a mirror 2229, so as to allow the user to properposition the pair assembly 2221 in line with the skin of the BTT 2187 atthe eyelid area. It is contemplated that sensing device 2219 cancomprise a mirror in which electronics, display, and pair assembly 2221are mounted in said mirror, allowing thus measurement of temperature andconcentration of analytes being performed any time the user look at themirror. It is understood that any of the embodiments of the presentinvention can include a mirror for accurate measurements and properalignment of a sensor with the BTT.

FIG. 86P(4) is an exemplary sensing device 2239 for non-contactmeasurements at the brain tunnel 2187, said sensing device 2239 mountedon a support structure 2267, such as a wall or on an article ofmanufacture or an electronic device including a refrigerator, atelevision, a microwave, an oven, a cellular phone, a photo camera,video camera, and the like. In this embodiment just performing routineactivities such as opening a refrigerator door allows the user to checkcore temperature, measure glucose, check for cancer markers, and thelike. The spectral information contained in the radiation from the braintunnel is captured by a sensor slidably located on those electronicdevices and articles to align with different height individuals. Tobetter align the brain tunnel area 2187 with the sensing device 2239, alight source 2241, such as LED or other confined light source is used.When the eye 2243 of the user is aligned with the light 2241 projectingfrom a tube or other light path confining or constricting device, theBTT area is aligned with the light source-light detector pair 2251located at a predetermined distance from the eye. Light source 2253directs radiation 2255 at the brain tunnel 2187 which contains molecules2205 (including analytes such as glucose, cholesterol, ethanol, and thelike), said radiation 2255 generating a reflected radiation 2257 thatcontains the radiation signature of the analyte being measured. Thereflected radiation 2257 is then detected by detector 2259. Theelectrical signal generated by the detector 2259 is then fed to aprocessing circuit 2261 which is operatively coupled with memory 2263,and display 2265. It is understood that an iris scanner, a retinalscanner, or the like or any biometric device such as finger printdetectors or camera-like device can be coupled with sensing device 2239.In this embodiment, the pair light source-light detector is preferablyreplaced by a detector such as for example a thermopile or array ofthermopile as previously described in the present invention.Accordingly, light source 2241 can include or be replaced by an irisscanner which identifies a person while measuring the person's core bodytemperature. This embodiment can be useful at port of entries such asairports in order to prevent entry of people with undetected fever whichcould lead to entry of fatal disorders such as SARS, bird flu,influenza, and others. The temperature of the person, measured by thesensor aimed at the BTT, is coupled to the identity of the personacquired through the iris scanning, with said data temperature-iris scanbeing stored in a memory. The system may include a digital camera,allowing a picture of the person being coupled with the body coretemperature and the iris scan. A processor identifies whether thetemperature is out of range, and activates an alarm when fever isdetected. The system allows measurement of temperature and concentrationof analytes being performed any time the user look at the iris scanner.

It is understood that a sensor for detecting radiation or capturing asignal from the brain tunnel can be mounted on any device or article ofmanufacturing. Accordingly and by way of further illustration, FIG.86P(5) shows a sensing device 2273 including a sensor 2269 mounted on aweb-camera 2271 which is secured to a computer 2275 for measurements ofradiation from the brain tunnel 2187, said sensing device 2273 having acord 2277 which is connected to computer 2275 and carries an electricalsignal generated by detector 2269, with the electrical signal being fedinto the computer 2275. In this embodiment, the processor, display andother electronics are housed in the computer. Any time a user looks atthe web-camera, measurement of body temperature and/or determination ofconcentration of analyte can be accomplished.

FIG. 86Q is a side cross-sectional view of sensing device 2000 showingin detail measuring portion 2006. Measuring portion 2006, asillustrated, includes two portions, external part 2162 and internal part2164, said parts 2162, 2164 having different diameters. Measuringportion 2006 is comprised preferably of a two level (or two heightstructure) 2163. The external part 2162 has a larger diameter ascompared to the internal part 2164. The height (or thickness) ofinternal part 2164 is of greater dimension than the height (orthickness) of external part 2162. Each part, external part 2162 andinternal part 2164, has preferably a different thickness (or height).External part 2162 and internal part 2164 connect to free end 2165 ofarm 2161, said arm 2161 terminating in body 2159.

Measuring portion 2006 has an essentially circular configuration and hasa wire portion 2166 disposed in the internal part 2164. External part2162 can comprise a washer or ring around internal part 2164. Internalpart 2164 has preferably a cylindrical shape and houses wire portion2166 inside its structure and houses sensor 2170 at its free end. Wireportion 2166 terminates in wire portion 2167 secured to arm 2161.Although a circular configuration is shown, any other shape orcombination of shapes is contemplated.

FIG. 86Q(1) is a perspective diagrammatic view of measuring portion 2006of FIG. 86Q showing two tiered external part 2162 and internal part2164, said internal part 2164 housing wire 2166 which terminates insensor 2170. In order to fit the brain tunnel, specialized geometry anddimensions are necessary. The preferred diameter (or length incase of anon-circular shape) of part 2162 is equal to or no greater than 3.0 cm,and preferably equal to or no greater than 1.5 cm in diameter or length,and most preferably equal to or no greater than 1.0 cm in diameter orlength. For a non-circular configuration that includes a width, thepreferred width of part 2162 is equal to or no greater than 3.0 cm, andpreferably equal to or no greater than 2.0 cm in width, and mostpreferably equal to or no greater than 1.0 cm in width. The preferredheight (or thickness) of part 2162 is equal to or no greater than 3.5cm, and preferably equal to or no greater than 2.5 cm in thickness, andmost preferably equal to or no greater than 1.5 cm in thickness, andmuch more preferably equal to or no greater than 0.5 cm in thickness.The preferred largest dimension of part 2162 is no greater than 3.5 cm,and preferably no greater than 2.0 cm, and most preferably no greaterthan 1.5 cm.

Part 2164 has preferably an essentially cylindrical configuration,although any other configuration or geometry is contemplated and can beused in accordance with the invention. The preferred diameter of part2164 is equal to or no greater than 3.0 cm, and preferably equal to orno greater than 2.0 cm in diameter or length, and most preferably equalto or no greater than 1.0 cm. For a non-circular configuration thatincludes a width, the preferred width of part 2164 is equal to or nogreater than 3.0 cm, and preferably equal to or no greater than 1.5 cmin width, and most preferably equal to or no greater than 1.0 cm inwidth. The preferred height (or thickness) of part 2164 is equal to orno greater than 3.5 cm, and preferably equal to or no greater than 2.5cm, and most preferably equal to or no greater than 1.0 cm, and muchmore preferably equal to or no greater than 0.7 cm. The preferredlargest dimension of part 2164 is no greater than 3.5 cm, and preferablyno greater than 2.0 cm in diameter or length, and most preferably nogreater than 1.5 cm.

For temperature monitoring, preferably, part 2162 and part 2164 are madewith an insulating material such as polyurethane, polypropylene,thinsulate, and the like, however, other materials are contemplated,including other polymers, foams, and the like. Part 2162 and part 2164preferably comprise a compressible material for certain applications.

FIG. 86R shows a diagrammatic perspective view of sensing device 2000including plate 2180, said plate 2180 having preferably a soft andflexible portion 2172, such as a pad, for cushion, said pad includingfoam, silicone, polyurethane, or the like, with said soft portion 2172having an adhesive surface 2174 which is covered by a peel back cover2176. When in use the cover 2176 is removed by pulling tab 2175, and theadhesive surface 2174 is applied to the skin, preferably on the skin ofthe forehead or any other part of the face and head, but any other bodypart is suitable and can be used to secure securing plate 2180. Plate2180 further comprises preferably an essentially semi-rigid portion2281, said semi-rigid portion 2281 being connected to soft portion 2172.Semi-rigid portion 2281 can preferably comprise a thin metal sheet suchas a metal with memory shape as steel. Semi-rigid portion 2281 can alsoinclude plastics and polymers. It is understood that preferably saidsemi-rigid portion 2281 has flexible characteristics to conform to abody part. Although semi-rigid portion 2281 is disclosed as a preferredembodiment, alternatively, plate 2180 can function only with softportion 2172.

Rigid portion 2281 of plate 2180 continues as arm 2184, said arm 2184having a free end 2188 which connects to measuring portion 2186.Measuring portion 2186 includes sensor 2190, said sensor 2190 ispreferably disposed as a bulging portion. During use the method includesthe steps of, applying plate 2180 to the skin, bending arm 2184 to fitwith the particular anatomy of the user and for positioning the sensor2190 on or adjacent to the skin of the BTT or other tunnels of theinvention. Other steps include measuring an analyte or analyzing atissue, producing a signal corresponding to the measurement andanalysis, and reporting the results. Further steps can includeprocessing the signal and displaying the result in alphanumericalformat, audible format, a combination thereof and the like. A furtherstep can include transmitting the signal to another device using awireless or wired transmitter. The step of chemical measuring an analytecan be replaced by measuring a physical parameter such as temperature,pulse, or pressure.

FIG. 86R(1) shows a schematic view of sensing device 2289 when worn by auser 2293 and including a headband 2283 around the forehead, saidheadband 2283 attached to plate 2291, said plate 2291 having arm 2285and a sensor 2287 which receives radiation from the brain tunnel 2187.

FIG. 86R(2) shows a schematic view of sensing device 2295 having aswivel mechanism 2297 at the junction of arm 2299 and body 2301, saidswivel mechanism allowing rotation and motion of arm 2299 (representedby broken arrows) for positioning sensor 2303 on or adjacent to a braintunnel. Sensor 2303 is illustrated as a light source-detector pair, withwire 2305 connecting said sensor 2303 to a processing and display unit2307.

FIG. 86R(3) shows the embodiment of FIG. 86R(2) when worn by a user2309, and depicting light source-detector pair 2303 positioned on thebrain tunnel 2187. Body 2301 is secured to the forehead 2311 preferablyby adhesive means 2313 disposed at the inner surface of body 2301, saidbody 2301 connected to arm 2299 by swivel mechanism 2297, which ispreferably positioned over the eyebrow.

FIG. 86S(1) shows a side view of sensing device 2000 including wire 2198which is disposed flat and without any bending, and runs from sensor2210 in measuring portion 2196 to body 2192. Measuring portion 2196 isaligned with arm 2194 and body 2192. In this embodiment, the axis ofmeasuring portion 2196 is in line with arm 2194, and forms a 180 degreeangle. During fabrication the 180 degree angle configuration and flatshape is obtained. During use, in accordance with the method of theinvention, the arm 2194 is bent. Since arm 2194 is flexible andadjustably positionable, during use arm 2194 is bent for positioningmeasuring portion 2196 in line with the brain tunnel.

Accordingly, FIG. 86S(2) shows sensing device 2000 worn by a user witharm 2194 bent in order to position sensor 2210 of measuring portion 2196on or adjacent to brain tunnel area 2214 between the eyebrow 2212 andeye 2216. Wire 2198 connects sensor 2210 to body 2192, said body 2192being preferably secured to the forehead.

Sensing device 2000 can be powered by active power including batteriessecured to body 2002, solar power, or by wires connecting sensing device2000 to a processing unit. It is also understood that any of the sensorshoused in an adhesive patch or housed in support structure 2000 canoperate on a passive basis, in which no power source is housed in saidsensor system. In the case of passive systems, power can be providedremotely by electromagnetic waves. An exemplary embodiment includesRadio Frequency ID methodology, in which a nurse activates remotely thepatch or sensor system 2000 of the present invention which then reportsback the identification of the patient with the temperature beingmeasured at the time of activation. The sensor system can also include atransponder which is powered remotely by a second device, which emits aradio signal or any suitable electromagnetic wave to power the sensorsystem. Besides temperature, any other biological parameter can bemeasured such as pulse, blood pressure, levels of chemical substancessuch as glucose, cholesterol, and the like in addition to blood gases,oxygen levels, oxygen saturation, and the like.

It is yet understood that arm 2004 connected to measuring portion 2006can be detachably connected to plate 2002, with said arm 2004 andmeasuring portion 2006 becoming a disposable part while plate 2002,which preferably houses expensive wireless transmitter and otherelectronics and power source, works as the durable part of the device2000. It is also understood that measuring portion 2006 can bedetachably connected to arm 2004, said measuring portion 2006 beingdisposable. It is yet understood that the free end of measuring portion2006 can be connected to a wire inside body 2020 of measuring portion2006, said free end housing sensor 2010 being the disposable part. It isalso contemplated that the present invention is directed to a method andapparatus in which the disposable part is the body 2002 and the durablereusable part is the measuring portion 2006 and arm 2004. In thisembodiment an expensive sensor such as an infrared detector can bedisposed in the measuring portion 2006, and is detachably connected toplate 2002, said sensor being the reusable part while the body 2002being the disposable part. Accordingly, FIG. 86T(1) shows sensing device2000 including arm 2004, measuring portion 2006 with sensor 2010, andplate 2002, said plate 2002 housing a circuit board 2200 including aprocessor 2222 operatively coupled to a memory 2228, power source 2224,and transmitter 2226. Wire 2220 connects sensor 2010 to circuit board2200.

FIG. 86T(2) shows an exemplary embodiment of sensing device 2000comprised of two separable pieces including a durable part 2230,represent by the body, and a disposable part 2232, represented by thearm and measuring portion. It is understood that sensing device cancomprise one or more parts and a combination of durable and disposableparts. Accordingly, in FIG. 86T(2) there is seen durable part 2230represented by plate 2002, said plate 2002 having a circuit board 2200including processor 2222 operatively coupled to a memory 2228, powersource 2224, and transmitter 2226. Disposable part 2232 comprises arm2204 and measuring portion 2006. Plate 2002 has an electrical connector2234 which is electrically and detachably connected to an electricalconnector 2236 of arm 2004, preferably creating a male-female interfacefor electrical connection in which wire 2220 of arm 2004 ends as a maleconnector 2236 adapted to connect to a female connector 2234 of plate2002.

FIG. 86T(3) shows an exemplary embodiment of sensing device 2000comprised of two separable pieces including a durable part 2240 furthercomprised of arm 2004 and plate 2002 and a disposable part 2242comprised of measuring portion 2006, said measuring portion 2006including a light emitter-light detector pair 2244. Arm 2004 has anelectrical connector 2246 which is electrically and detachably connectedto an electrical connector 2248 of measuring portion 2006.

It is contemplated that durable part represented by plate 2002 cancomprise power source and a LED for alerting changes in the biologicalparameter being measured or to identify that the useful life of thedevice has expired. Plate 2002 can also house a power source and awireless transmitter, or a power source and a display for numericaldisplay, or/and a combination thereof. Alternatively plate 2002 works asa passive device and comprises an antenna and other parts forelectromagnetic interaction with a remote power source. Anotherembodiment includes a passive device or an active device comprised of apatch having a sensor and a LED, said LED being activated when certainvalues are detected by the sensor, allowing a nurse to identify forexample a patient with fever by observing a patch in which the LED is onor flashing.

Any biological parameter and tissue can be measured and/or analyzed atthe brain tunnel including temperature, concentration of chemicalsubstances, blood pressure, pulse, and the like. Exemplarily a blood gasanalyzer and a chemical analyzer will be described. The embodimentrelates to a device for the transcutaneous electrochemical or opticaldetermination of the partial pressure of oxygen and/or analytes in theblood of humans or animals at the Brain Temperature Tunnel (BTT) site,also referred to as brain tunnel (BT). The invention comprises ameasuring portion 2006 which includes a measuring cell havingelectrodes, said cell having a surface which is to be disposed incontact with the skin at the BTT. The cell in measuring portion 2006 caninclude a heating or a cooling element for changing the temperature ofthe brain tunnel. Preferably the measuring portion 2006 includes anelectrical heating element. Besides contacting the skin, the measuringsurface of measuring portion 2006 can be spaced away from the skin atthe brain tunnel for measuring analytes and the partial pressure ofoxygen.

For measurement of oxygen the measuring portion 2006 preferably includesa Clark type sensor, but it is understood that any electrochemical oroptical system can be used in accordance with the present invention andfall within the scope of the present invention. Various sensors,electrodes, devices including polarygraphic sensors, enzymatic sensors,fluorescent sensors, optical sensors, molecular imprint, radiationdetectors, photodetectors, and the like can be used.

In one preferred embodiment, the measuring portion 2006 includes anelement to increase blood flow, such as by way of illustration, aheating element, a suctioning element, or fluid that increasespermeability of skin. Preferably a heating element is provided, wherebythe sensing surface (or measuring surface) of the measuring portion 2006is adapted to increase the temperature of the skin at the brain tunnel.This heating element increases blood flow to the entrance of the BT andaccelerates the oxygen diffusion through the skin at the BT. Themeasuring portion 2006 is preferably located in apposition to the BTzone associated with the arterial supply and the orbital artery or anyof the arterial branches located in the BT area, in order to achieveideal measurement of the arterial oxygen and the arterial partial oxygenpressure. The transcutaneously measured oxygen pressure on the skin atthe entrance of the BT is obtained by placing a specialized measuringportion 2006 of special geometry and dimensions on the skin at the BTT,in accordance with the present invention and the specialized dimensionsand shape of the sensor and support structures as described herein.

In arterial blood an equilibrium exists between the percentage ofoxidized hemoglobin and the partial oxygen pressure. When the blood isheated, this equilibrium is shifted so that the partial oxygen pressureincreases. Therefore, when the BT method is used, the partial oxygenpressure in the peripheral blood vessels in the BT is higher than in thearteries. The oxygen coming from the arterial region of the BT diffusesthrough the skin at the BTT.

With exception of the skin at the BT, the skin cells in the whole bodyconsume oxygen during diffusion of oxygen through the skin, because saidskin is thick and has a thick underlying layer of subcutaneous tissue(fat tissue). Thus, the oxygen pressure at the area of the epidermis inall areas of the body, with exception of the BT area, is much lower thanthe actual oxygen pressure in the peripheral blood vessels. However, inthe specialized skin areas of the BT the oxygen levels remain stablesince the skin at the BT is the thinnest skin in the whole body and freeof adipose (fat) tissue.

The specialized skin area of the BT between the eyebrow and the eye, atthe roof of the orbit shown in FIG. 86U has stable levels of chemicalsubstances including oxygen, glucose, blood gases, drugs and analytes ingeneral. In FIG. 86U there is seen the BT area 2260 which includes theupper eyelid area 2250 and the roof of the orbit area 2252 located rightbelow the eyebrow 2254, and above the eye 2256. The BT area 2260 islocated below the eyebrow 2254, and between the eyebrow 2254 and the eye2256, with the nose 2258 forming another boundary of the BT area.Accordingly, FIG. 86U shows a first boundary formed by the eyebrow 2254,a second boundary formed by the eye 2256, and a third boundary formed bythe nose 2258, with the main entry point 2262 of the BT located at theroof of the orbit, in the junction between the nose 2258 and the eyebrow2254. A second physiologic tunnel is located in the area adjacent to thelower eyelid extending 10 mm below from the edge of the lower eyelid,however, the most stable area for measuring biological parameterscomprises the BT area 2260 with the main entry point 2262 at the roof ofthe orbit 2252 below the eyebrow 2254. In the BT area the blood gas,such as oxygen, and other molecules including glucose remains stable.

Since consumption of oxygen is proportional to the thickness of the skinand of subcutaneous tissue (which contains the fat tissue), and furtherconsidering that the BT, as described above and surroundingphysio-anatomic tunnels disclosed in the present invention have verythin skin and no subcutaneous tissue, the amount of oxygen at theepidermis (skin) at the entrance of said tunnels is not reduced, andremains proportional to the amount present in the peripheral bloodvessels. Thus, the amount of gases such as oxygen, carbon dioxide, andother gases as well as analytes present in the skin of the BTT isproportional to the amount present in blood.

Another advantage of the present invention is that the heating elementdoes not need to reach high levels of temperature, such as 44 degreesC., since the tunnel area is extremely vascularized and associated witha unique blood vessel which is terminal (which means that the totalamount of blood is delivered to the site) in addition to having thethinnest skin interface in the whole body, thereby allowing a lowertemperature of a heating element to be used for increasing blood flow tothe area. The preferred temperature of the heating element is equal toor less than 44 degrees Celsius, and preferably equal to or less than 41degrees Celsius, and most preferably equal to or less than 39 degreesCelsius, and even most preferably equal to or less than 38 degreesCelsius.

The electrochemical sensor of the measuring portion 2006 for blood gasand glucose analysis has the same specialized dimensions and shapedescribed for the other sensors of the invention, in accordance with thepresent invention and specialized anatomy of the BT and othersurrounding tunnels. The device includes a measuring portion 2006 havinga sensor, said sensor preferably being an electrochemical or opticalsensor, and an associated heating element of specialized dimensions,with said measuring portion 2006 located adjacent to the BT or on theskin at the BT or other described tunnels of the invention. One of theobjects of the invention includes providing a device of the describedkind to be used at the BT for measurement of the arterial oxygenpressure and other blood gases such as carbon dioxide, carbon monoxide,anesthetic gases, and the like.

FIG. 87 illustrates a comparison between transcutaneous measurement ofthe arterial oxygen pressure in the prior art and the present invention.FIG. 87 shows the skin 2270 with its three thick layers, which ispresent in the whole body. Methods of the prior art use this skin 2270,which has several thick layers, namely subcutaneous tissue (fat tissue)2272, thick dermis 2274, and thick epidermis 2276. Underneath this thickskin tissue 2270 there are small blood vessels 2278. Oxygen representedby small squares 2280 diffuses through the walls of the small bloodvessels 2278, as indicated by the two small arrows in each blood vessel2278. Contrary to the thick and multilayered skin 2270 present in otherparts of the body, which comprised the method used by the prior art, themethod and apparatus of the present invention uses specialized skin 2290at the BT 2282, which has a large vascular bed 2284, no fat issue, athin dermis 2286, and thin epidermis 2288. A large blood vessel andlarge vascular bed 2284 present in the brain tunnel provides more stableand more accurate level of molecules and substances such as oxygen levelas well as the level of other blood substances such as glucose. Contraryto the method of the prior art which tried to measure substances inareas subject to vasoconstriction and subject to the effect of drugs,the present invention teaches device and methods using a vascular bed2284 at the brain tunnel that is not subject to such vasoconstriction.

Skin 2270 of the prior art is thick and has a thick subcutaneous layer2272 in comparison with the thin skin 2290 of the BT. In the method ofthe prior art, oxygen molecules 2280 from small blood vessel 2278, whichis located deep in the body, have to cross thick layers of skin 21742(fat tissue), 2174 (dermis), 2176 (epidermis and dead cells) present insaid skin 2270 in order for said oxygen molecules 2280 to reach aconventional sensor of the prior art. Accordingly, in the method of theprior art the oxygen 2280 from vessel 2278 has a long path beforereaching a sensor of the prior art. Oxygen 2280 diffuses through thewall of the small blood vessel 2278 and through the subcutaneous tissue2272 to finally reach a thick dermis 2274 and a thick layer of deadcells 2276 at skin 2270, to only then reach conventional sensors of theprior art. As can be seen, the number of oxygen molecules 2280 dropdrastically from around vessel 2278 to surface of skin 2271 as it movesalong the long path of conventional thick skin 2270 present in the body.

Contrary to the prior art, the method and device of the presentinvention uses a specialized and extremely thin skin 2290 of the BT, inwhich oxygen molecules 2280 from vessel 2284 have an extremely shortpath to reach specialized sensor 2000 of the present invention. Oxygenmolecule 2280 is right underneath the thin skin 2290 since terminallarge vascular area 2284 lies just underneath the thin skin 2290, andthus oxygen 2280 rapidly and in an undisturbed fashion reachesspecialized sensor 2000. This allows an undisturbed diffusion of oxygenfrom vessel 2284 to sensor 2000 without any drop of the partial oxygenpressure. Because the specialized skin 2290 of the BT produces a rapidand undisturbed diffusion of oxygen (and other blood gases) to thespecial sensor 2000 of the present invention and the area measured ischaracterized by a natural condition of hyperperfusion, the presentinvention results in more accurate measurement than previously availableestimates of partial blood gas pressures.

An exemplary transcutaneous blood gas sensor of the present inventionconsists of a combined platinum and silver electrode covered by anoxygen-permeable hydrophobic membrane, with a reservoir of phosphatebuffer and potassium chloride trapped inside the electrode. FIG. 87Ashows a small heating element 2298, which is located inside the silveranode. Oxygen 2280 diffuses through the skin 2290 and reaches sensor2292 wherein a reduction of oxygen occurs generating a current that isconverted into partial pressure of oxygen. It is understood that othersubstances can be measured. Exemplarily, carbon dioxide can be measuredwith the invention, wherein carbon dioxide molecules diffuse across apermeable plastic membrane into the inner compartment of the electrodewhere the molecule reversibly reacts with a buffer solution altering thepH which produces a measurable signal, said signal corresponding to theamount of the substance or partial pressure of the gas. A processingcircuit can be used to calculate the partial pressure of the substancebased on predetermined calibration lines.

In reference to FIG. 87A, measuring portion 2006 of the sensor system isarranged on the skin 2290 at the BT 2282 and includes element 2294. Theelement 2294 can operate as a blood gas sensor, oxygen saturationsensor, glucose sensor, or any other sensor measuring blood substancesor body tissue. Sensing element 2294 in this embodiment includes aClark-type sensor 2292 for detecting oxygen molecule 2280 and a heatingelement 2298 which is adapted for periodical actuation for generatingheat. Measuring portion 2006 includes a cell 2300 and a temperaturesensor 2296. Cell 2300, which is the chemical sensing portion, includessensor 2292 and heating element 2298. The maximum preferred length ordiameter of cell 2300 is equal to or less than 2.5 cm, and preferablyequal to or less than 1.5 cm and most preferably equal to or less than1.0 cm as represented by line C to D. The sensing device 2000 isconnected to a processing circuit 2302 and power supply circuit 2304 viaa wire 2306. Measuring portion 2006 is secured onto the skin 2290 in acompletely leak-free manner, to avoid oxygen from the air reaching thesensor 2292. Preferably, the surface 2308 of measuring portion 2006 isprovided with an adhesive layer or other means for sealing. Surface 2310of sensor 2292 is preferably permeable to oxygen, carbon dioxide,glucose and any other blood components depending on the analyte beingmeasured. Measuring portion 2006 has a preferred maximum length ordiameter of equal to or less than 4 cm, and preferably equal to or lessthan 2.5 mm and most preferably equal to or less than 1.5 cm, asrepresented by line A to B in FIG. 87A.

The skin 2290 at the BT 2282 is heated by heating source 2298 adjacentto the area of sensor 2292 with consequent increase in arterial bloodflow. Electrodes and a voltage source in processing circuit 2302 providea circuit in which the electrical current flow is dependent on thepartial oxygen pressure at the sensor 2292.

Although a contact device and method was illustratively shown, it isunderstood that a non-contact method and device can be equally used inaccordance with the invention. It is also understood that a variety ofsupport structures, disclosed in the present invention, can be used forhousing the elements of measuring portion 2006 including adhesivepatches, head mounted gear such as eyewear and headbands, and the like.In addition to or as a substitute of wired transmission, thetransmission of the signal can use a wireless transmitter and the sensorsystem of the invention can include a wireless transmitter.

FIG. 87B shows sensor system 2320 which includes an essentially convexsensing surface 2322. Although a convex surface is illustrativelydescribed, a flat surface can also be used. Sensor system 2320 is areflectance sensor including a sensing portion comprised of two parts,the light emitter 2324, 2326 and the detector 2328, which receive thelight emitted from light emitter 2324, 2326. Sensor system 2320 uses aninfrared light source 2324, 2326 and detector 2328 in specialized padsthat are fixed firmly to the skin 2290 of the BT 2282 to detect regionalblood oxygen saturation. Sensing portion 2330 has a dimension from pointC to point D which is preferably equal to or less than 2.1 cm, and morepreferably equal to or less than 1.6 cm, and most preferably equal to orless than 1.1 cm. Sensor system 2320 includes a processing circuit 2332,said processing circuit 2332 including a processor which is coupled to awireless transmitter 2334 for wirelessly transmitting data, preferablyusing Bluetooth™ technology. The light emitter can include anear-infrared emitter. Any near infrared radiation source can be used.Preferably radiation having wavelengths between 700 to 900 nm are usedfor measurement of oxygen and other substances. Radiation sourcesinclude near-infrared wavelength. It is understood that radiation source2324, 2326 can also include mid-infrared wavelength. It is alsounderstood that radiation source 2324, 2326 can also includefar-infrared wavelength. It is also understood that radiation source2324, 2326 can also include a combination of various wavelengths or anyelectromagnetic radiation. The region of the spectrum and wavelengthused depend on the substance or analyte being measured. It is understoodthat a mid-infrared light source, having wavelength between 3,000 nm and30,000 nm can also be used. The light source can further include visiblelight and fluorescent light depending on the analyte or tissue beingevaluated.

FIG. 87C shows sensor 2340 which includes a specialized two planesurface formed by an essentially convex surface 2334 and a flat centralsurface 2336. The flat surface 2336 is preferably the sensing surface ofsensor 2340. The two plane surface convex-flat-convex allows preferredapposition to the skin 2290 at the BT 2282. Measuring portion 2006includes a reflectance sensor comprised of two parts, the light emitter2338 and a detector 2342, which receive the light emitted from lightemitter 2338. Measuring portion 2006 houses light emitter 2338, whichuses near infrared light or mid-infrared light source, and aphotodetector 2342, and a mechanical plunger 2344, which when poweredthrough wire 2346 elicit a rhythmic motion, gently tapping the skin 2290at the BT 2282, to increase perfusion in cases of hypoperfusion.Although a mechanical plunger is described, it is understood that anydevice or article that by motion compresses and decompresses the skin atthe BTT will create increased perfusion and can be used in the inventionas well as a suction cup and the like, all of which are within the scopeof the invention. Dimensions of measuring portion 2006 from point A1 topoint B1 have preferred maximum length or diameter of equal to or lessthan 3.1 cm, and preferably equal to or less than 2.1 cm and mostpreferably equal to or less than 1.6 cm.

Since the skin at the BT is highly oxygenated and has a high blood flow,the heating element or any element to cause increase blood flow is notnecessary in most patients. Accordingly, another preferred embodiment ofthe present invention is shown in FIG. 88, and said embodiment does notinclude a heating element. FIG. 88 shows a face with eyes 2350 and 2352,eyebrow 2354, and nose 2356, with sensing device 2000 including body2002, arm 2004, and measuring portion 2006 with sensor 2358 secured tothe skin above eye 2350 and below eyebrow 2354. By way of illustration,sensor 2358 works as a blood gas sensor previously described, saidsensor 2358 positioned on the skin at the brain tunnel or adjacent tothe skin 2290 at the brain tunnel, said sensor being in contact with theskin or spaced away from the skin at the brain tunnel duringmeasurement.

The device of the present invention is adapted to measure any componentpresent in the blood by utilizing a plurality of sensors adjacent to orin apposition to the skin of the BT and other physiologic and anatomictunnels of the present invention. It is understood that anelectrochemical sensor or optical sensor can be used to measure otherblood components such as glucose, carbon dioxide, cholesterol, pH,electrolytes, lactate, hemoglobin, and any of the blood components.

The sensor system of the invention includes skin surface oxygen pressuremeasurement, carbon dioxide pressure measurement and measurement of thearterial partial pressure of oxygen or carbon dioxide by locallyapplying a specialized device on the skin at the BTT comprised by thevarious new and specialized supports structures. A processing circuituses the skin surface oxygen or carbon dioxide pressure at the BTT andother tunnels of the invention to calculate the arterial partialpressure of oxygen or carbon dioxide. The processing circuit can beoperatively coupled to a memory for correlating the acquired value witha stored value. A processing circuit can be further coupled to a displayfor visual or audible reporting of the values.

The present invention also discloses a method comprising the steps ofapplying a electrochemical sensor or an optical sensor or a radiationdetector on or adjacent to the skin at the entrance of the BT and othertunnels, applying electrical energy, and measuring at least one analyteincluding at least one of glucose, oxygen, cholesterol, oxygen, andcarbon dioxide. An alternative step includes increasing blood flow tothe area by using at least one of heating, creating suction,mechanically tapping the area, using sound waves such as ultrasound,increasing BT skin permeability with laser light, increasing BT skinpermeability with chemical substances, and the like.

Sensor 2358 can also work as an infrared detector for measurement ofanalytes such as glucose. Likewise sensor 2358 can operate as a lightemitter-detector pair for measuring analytes. The noninvasivemeasurement methods of the present invention takes advantage that the BTis an ideal emitter of infrared radiation at precisely the rightspectral radiation for measuring substances such as glucose. Theemission from the BT works as a black body emission. The emission fromthe BT contains the radiation signature of analytes. Contrary to otherparts of the body in which radiation is deep inside the body, theradiation at the BT is the closest to the surface of the body. A varietyof cooling or heating elements can be incorporated to enhancemeasurement of glucose at the BT. Besides mid-infrared radiation, it isalso understood that near-infrared spectroscopy can be used of themeasurement of glucose at the BTT. It is also understood thatmid-infrared spectroscopy can be used of the measurement of glucose atthe BTT. It is also understood that far-infrared spectroscopy can beused of the measurement of glucose at the BTT.

Furthermore, techniques such as Raman spectroscopy can also be used formeasuring the concentrations of blood analytes at the BTT and othertunnels of the present invention. Raman spectroscopy has sharp spectralfeatures, which are characteristic for each molecule. This strength isideally suited to blood analyte measurements, where there are manyinterfering spectra, many of which are much stronger that that of bloodanalytes. Accordingly, in the present invention Raman light is generatedin the tissue at the BT and collected by a mirror secured to any of thesupport structures of the present invention such as the frame ofeyeglasses, clips, adhesive patches attached to the skin, finger likestructure with a plate and an arm, and the like. A fiber bundle in anyof the support structures of the present invention guides the collectedRaman light to a portable spectrograph and/or to a processor and a CCD.Since there are no interfering elements at the BT, the Raman's sharpspectral features enable accurate detection of blood analyte spectraincluding glucose, urea, triglyceride, total protein, albumin,hemoglobin and hematocrit.

A light source can illuminate the skin at the brain tunnel area andgenerate a detectable Raman spectrum for detecting analytes based onsaid spectrum. Accordingly, another embodiment of the present inventionincludes an apparatus and method for the non-invasive determination ofan analyte comprising a light source for generating an excitation lightdirected into the brain tunnel and an optical system coupled with saidexcitation light, said optical system configured for directing theexcitation light into the brain tunnel to generate a detectable Ramanspectrum thereof, a light detector coupled with said optical system andconfigured to detect a Raman spectrum from the brain tunnel, a processoroperatively coupled with said detector said processor including aprocessing circuit, said processing circuit having a computer readablemedium having code for a computer readable program embodied therein forcomparing Raman spectrum from the brain tunnel to a reference radiationcorresponding to the concentration of an analyte, and a memoryoperatively coupled with said processor. The electrical signalcorresponding to Raman spectrum from the brain tunnel is fed into theprocessing circuit and compared to Raman spectrum from the brain tunnelcorresponding to the analyte concentration stored in the memory.

It is also understood that glucose at the BTT can be measured withenzymatic sensors such as glucose oxidase as well as artificial glucosereceptors. Fluorescence techniques can also be used and include use ofengineered molecules, which exhibit altered fluorescence intensity orspectral characteristics upon binding glucose, or use of competitivebinding assays that employ two fluorescent molecules in the fluorescentresonance energy transfer technique. In addition, “reverseiontophoresis”, with a device held in the specialized support structuresof the invention such as eyeglasses can be used, and interstitial fluidfrom the BT area removed for analysis. Ultrasound applied to the BTand/or a low-level electrical current on the skin of the BT, byconvective transport (electro-osmosis) can also be used for movingglucose across the thin skin of the BT and other tunnels around the eye.In addition, light scattering and photoacoustic spectroscopy can be usedto measure various substances such as glucose. Pulsed infrared lightdirected at the BT, when absorbed by molecules, produces detectableultrasound waves from the BT, the intensity and patterns of which can beused to measure glucose levels. The apparatus and methods of the presentinvention then determines the concentration of an analyte using aprocessor that correlates signals from the brain tunnel with a referencetable, said reference table having values of analytes corresponding tosignals from the brain tunnel.

Furthermore, a detector having an ultrasound and a light sourceilluminates the skin at the rain tunnel area with a wavelength that isabsorbed by the analyte being measured and generates a detectableultrasound wave from the brain tunnel for detecting analytes based onsaid ultrasound wave and light absorption. Accordingly, anotherembodiment of the present invention includes an apparatus and method forthe non-invasive determination of an analyte comprising a light sourcefor generating light directed into the brain tunnel and an ultrasoundconfigured to waves generated from the brain tunnel, a processoroperatively coupled with said ultrasound said processor including aprocessing circuit, said processing circuit having a computer readablemedium having code for a computer readable program embodied therein forcomparing absorption of radiation from the brain tunnel based on thesignal from the ultrasound to a reference radiation corresponding to theconcentration of an analyte, and a memory operatively coupled with saidprocessor. The electrical signal corresponding to the intensity of soundwaves is used to determine radiation absorption of light from the braintunnel, which is used to determine the concentration of the analyte,said signal being fed to the processing circuit and compared with theradiation absorption from the brain tunnel corresponding to the analyteconcentration stored in the memory.

The present invention includes non-invasive optical methods and devicesfor measuring the concentration of an analyte present in the BT. Avariety of optical approaches including infrared spectroscopy,fluorescent spectroscopy, and visible light can be used in the presentinvention to perform the measurements in the BT including transmission,reflectance, scattering measurement, frequency domain, or for examplephase shift of modulated light transmitted through the substance ofinterest or reflected from the BT, or a combination thereof.

The present invention includes utilizing the radiation signature of thenatural black-body radiation emission from the brain tunnel. Naturalspectral emissions of infrared radiation from the BT and vessels of theBT include spectral information of blood components such as glucose. Theradiation emitted by the BT as heat can be used as the source ofinfrared energy that can be correlated with the identification andmeasurement of the concentration of the substance of interest. Infraredemission in the BT traverses only an extremely small distance from theBT to the sensor which means no attenuation by interfering constituents.The devices and methods can include direct contact of the instrumentwith the skin surface at the BT or the devices of the invention can bespaced away from the BT during the measurements.

The methods, apparatus, and systems of the present invention can usespectroscopic analysis of the radiation from the BT to determine theconcentration of chemical substances present in such BT while removingor reducing all actual or potential sources of errors, sources ofinterference, variability, and artifacts. The natural spectral emissionfrom the BT changes according to the presence and concentration of asubstance of interest. One of the methods and apparatus involves using aradiation source to direct electromagnetic radiation at the BT with saidradiation interacting with the substance of interest and being collectedby a detector. Another method and apparatus involves receivingelectromagnetic radiation naturally emitted from the BT with saidradiation interacting with the substance of interest and being collectedby a detector. The data collected is then processed for obtaining avalue indicative of the concentration of the substance of interest.

The infrared thermal radiation emitted from the brain tunnel followPlanck's Law, which can be used for determining the concentration ofchemical substances. One embodiment includes determining the radiationsignature of the substance being measured to calculate the concentrationof the substance. Another embodiment includes using a referenceintensity calculated by measuring thermal energy absorption outside thesubstance of interest band. The thermal energy absorption in the band ofsubstance of interest can be determined via spectroscopic means bycomparing the measured and predicted values at the BT. The signal isthen converted to concentration of the substance of interest accordingto the amount of infrared energy absorbed.

The apparatus uses the steps of producing output electrical signalsrepresentative of the intensity of the radiation signature and sendingthe signal to a processor. The processor is adapted to provide thenecessary analysis of the signal to determine the concentration of thesubstance of interest and is coupled to a display for displaying theconcentration of the substance of interest, also referred to herein asanalyte.

The analyte measured or detected can be any molecule, marker, compound,or substance that has a radiation signature. The radiation signaturepreferably includes a radiation signature in the infrared wavelengthrange including near-infrared, mid-infrared, and far-infrared. Theanalyte being measured can preferably have a radiation signature in themid-infrared range or the near infrared range.

Infrared spectroscopy, as used in some embodiments of the presentinvention, is a technique based on the absorption of infrared radiationby substances with the identification of said substances according toits unique molecular oscillatory pattern depicted as specific resonanceabsorption peaks in the infrared region of the electromagnetic spectrum.Each chemical substance absorbs infrared radiation in a unique mannerand has its own unique absorption spectra depending on its atomic andmolecular arrangement and vibrational and rotational oscillatorypattern. This unique absorption spectra allows each chemical substanceto basically have its own infrared spectrum, also referred asfingerprint or radiation signature which can be used to identify each ofsuch substances.

In one embodiment radiation containing various infrared wavelengths isemitted at the substance or constituent to be measured, referred toherein as “substance of interest”, in order to identify and quantifysaid substance according to its absorption spectra. The amount ofabsorption of radiation is dependent upon the concentration of saidchemical substance being measured according to Beer-Lambert's Law.

One embodiment includes a method and apparatus for analyte measurement,such as blood glucose measurement, in the near infrared wavelengthregion between 750 and 3000 nm and preferably in the region where thehighest absorption peaks are known to occur, such as the radiationabsorption signature of the substance being measured. For glucose, forexample, the near infrared region includes the region between 2080 to2200 nm and for cholesterol the radiation signature is centered around2300 nm. The spectral region can also include visible wavelength todetect other chemical substances including glucose or cholesterol.

The apparatus includes at least one radiation source from infrared tovisible light which interacts with the substance of interest and iscollected by a detector. The number and value of the interrogationwavelengths from the radiation source depends upon the chemicalsubstance being measured and the degree of accuracy required. As thepresent invention provides reduction or elimination of sources ofinterference and errors, it is possible to reduce the number ofwavelengths without sacrificing accuracy. Previously, the mid-infraredregion has not been considered viable for measurement of analytes inhumans because of the presence of fat tissue and the high waterabsorption that reduces penetration depths to microns. The presentinvention can use this mid-infrared region since the blood with thesubstance of interest is located very superficially in an area void offat tissue which allows sufficient penetration of radiation to measuresaid substance of interest.

The present invention reduces variability due to tissue structure,interfering constituents, and noise contribution to the signal of thesubstance of interest, ultimately substantially reducing the number ofvariables and the complexity of data analysis, either by empirical orphysical methods. The empirical methods including Partial Least Squares(PLS), principal component analysis, artificial neural networks, and thelike while physical methods include chemometric techniques, mathematicalmodels, and the like. Furthermore, algorithms were developed usingin-vitro data which does not have extraneous tissue and interferingsubstances completely accounted for as occurs with measurement in deeptissues or with excess background noise such as in the skin with fattissue. Conversely, standard algorithms for in-vitro testing correlatesto the in vivo testing of the present invention since the structures ofthe brain tunnel approximates a Lambertian surface and the skin at thebrain tunnel is a homogeneous structure that can fit with thelight-transmission and light-scattering condition characterized byBeer-Lambert's law.

Spectral radiation of infrared energy from the brain tunnel cancorrespond to spectral information of the substance of interest oranalyte. These thermal emissions irradiated as heat at 38 degreesCelsius can include the 3,000 nm to 30,000 nm wavelength range, and moreprecisely the 4,000 nm to 14,000 nm range. For example, glucose stronglyabsorbs light around the 9,400 nm band, which corresponds to theradiation signature of glucose. When mid-infrared heat radiation isemitted by the brain tunnel, glucose will absorb part of the radiationcorresponding to its band of absorption. Absorption of the thermalenergy by glucose bands is related in a linear fashion to blood glucoseconcentration in the brain tunnel.

The infrared radiation emitted by the BTT contains the radiationsignature of the substance being measured and the determination of theanalyte concentration is done by correlating the spectralcharacteristics of the infrared radiation emitted from the brain tunnelto the analyte concentration for that radiation signature. The analyteconcentration can be calculated from the detected intensity of theinfrared radiation signature, said radiation signature generating anelectrical signal by a detector, with said signal being fed into amicroprocessor. The microprocessor can be coupled to a memory whichstores the concentration of the analyte according to the intensity ofthe radiation signature of the analyte being measured. The processorcalculates the concentration of the substance based on the stored valuein the memory. The processor is operatively coupled with said detector,said processor including a processing circuit, said processing circuithaving a computer readable medium having code for a computer readableprogram embodied therein for comparing infrared spectrum from the braintunnel to a reference radiation corresponding to the concentration of ananalyte, and a memory operatively coupled with said processor. Theelectrical signal corresponding to the infrared spectrum from the braintunnel is fed into the processing circuit and compared to infraredspectrum from the brain tunnel corresponding to the analyteconcentration stored in the memory. The infrared spectrum preferablyincludes near-infrared or mid-infrared radiation.

One embodiment includes a device and method for measuring an analyteconcentration in the blood or tissue of the BT. One embodiment includesdetecting the level of infrared radiation naturally emitted from the BT.One embodiment includes detecting the level of infrared radiationemitted from the BT after directing radiation at the BTT.

One embodiment includes a device which measures the level ofmid-infrared radiation from the surface of a brain tunnel and determinesthe concentration of an analyte based on the analyte's infraredradiation signature. The radiation signature can be preferably in theinfrared region of the spectrum including near-infrared or mid-infrared.The device can include a filter, a detector, a microprocessor and adisplay.

A detector having a light source can illuminate the skin at the braintunnel area and generate a detectable infrared radiation for detectinganalytes based on said infrared spectrum. The detectable infraredradiation from the brain tunnel contains the radiation signature of theanalyte being measured. Accordingly, another embodiment of the presentinvention includes an apparatus and method for the non-invasivedetermination of an analyte comprising a light source for generating aninfrared light directed into the brain tunnel and an infrared radiationdetector configured to detect infrared radiation from the brain tunnel,a processor operatively coupled with said detector, said processorincluding a processing circuit, said processing circuit having acomputer readable medium having code for a computer readable programembodied therein for comparing infrared radiation from the brain tunnelto a reference radiation corresponding to the concentration of ananalyte, and a memory operatively coupled with said processor. Theelectrical signal corresponding to infrared radiation signature from thebrain tunnel is fed into the processing circuit and compared to infraredradiation signature from the brain tunnel corresponding to the analyteconcentration stored in the memory.

A variety of radiation sources can be used in the present inventionincluding LEDs with or without a spectral filter, a variety of lasersincluding diode lasers, a Nernst glower broad band light emitting diode,narrow band light emitting diodes, NiChrome wire, halogen lights aGlobar, and white light sources having maximum output power in theinfrared region with or without a filter, and the like. The radiationsources have preferably enough power and wavelengths required for themeasurements and a high spectral correlation with the substance ofinterest. The range of wavelengths chosen preferably corresponds to aknown range and includes the band of absorption for the substance ofinterest or radiation signature of the substance. The instrumentcomprises a light source which may be any suitable infrared lightsource, including mid-infrared light source, near-infrared light source,far-infrared light source, fluorescent light source, visible lightsource, radio waves, and the like.

A light source can provide the bandwidth of interest with said lightbeing directed at the substance of interest in the brain tunnel. Avariety of filters can be used to selectively pass one or morewavelengths which highly correlate with the substance of interest. Thefilter can select the wavelength and includes bandpass filter,interference filter, absorption filter, monochromator, gratingmonochromator, prism monochromator, linear variable filter, circularvariable filter, acousto-optic tunable filter, prism, and any wavelengthdispersing device

The radiation can be directly emitted from a light source and directlycollected by a photodetector, or the radiation can be delivered andcollected using optic fiber cables. An interface lens system can be usedto convert the rays to spatial parallel rays, such as from an incidentdivergent beam to a spatially parallel beam.

The detector can include a liquid nitrogen cooled detector, asemiconductor photodiode with a 400 μm diameter photosensitive areacoupled to an amplifier as an integrated circuit, and the like. Thephotodetector has spectral sensitivity in the range of the lighttransmitted. The photodetector receives an attenuated reflectedradiation and converts the radiation into an electrical signal. Thedetector can also include a thermocouple, a thermistor, and amicrobolometer.

Analyte as used herein describes any particular substance to bemeasured. Infrared radiation detector refers to any detector or sensorcapable of registering infrared radiation. Examples of a suitableinfrared radiation detectors, include but are not limited to, amicrobolometer, a thermocouple, a thermistor, and the like. The combineddetected infrared radiation may be correlated with wavelengthscorresponding to analyte concentrations using means such as a Fouriertransform.

The BT provides the mid-infrared radiation signature and thenear-infrared radiation signatures of the analytes present therein. Theinfrared radiation signature from the BT is affected by theconcentration of analytes in the BT. One of the molecules present in theBT is glucose, and the natural mid-infrared or near-infrared radiationsignature of glucose contained within the brain tunnel's naturalinfrared radiation allows the non-invasive measurement of glucose.Changes in the concentration of certain analytes such as glucose,cholesterol, ethanol, and others, may cause an increase or change in thebrain tunnel's natural emission of infrared radiation which can be usedto measure the concentration of an analyte.

The BT emits electromagnetic radiation within the infrared radiationspectrum. The spectral characteristics of the infrared radiation emittedby the BT can be correlated with the concentration of analyte. Forexample, glucose absorbs mid-infrared radiation at wavelengths betweenabout 8.0 microns to about 11.0 microns. If mid-infrared radiationpasses through or reflects from the brain tunnel where glucose ispresent, a distinct radiation signature can be detected from theattenuated radiation or the remaining radiation that is not absorbed bythe analyte. The absorption of some amount of the radiation that isapplied to the brain tunnel (which contains the substance of interest),may result in a measurable decrease in the amount of radiation energy,which can be utilized to determine the concentration of an analyte.

One embodiment of the present invention provides a method and device fornon-invasively measuring the analyte concentration in blood or othertissues, and includes the steps of detecting mid-infrared radiationnaturally emitted by the brain tunnel, and determining the concentrationof said analyte by correlating the spectral characteristics or radiationsignature of the detected infrared radiation with a radiation signaturethat corresponds to the analyte concentration. The method can alsoinclude a filtering step before detection by filtering the naturallyemitted infrared radiation from the brain tunnel. In the case of glucosemeasurement, filtering allows only wavelengths of about 8,000 nanometersto about 11,000 nanometers to pass through the filter. The methodfurther includes a detecting step using an infrared radiation detector,which generates an electrical signal based on the radiation received andfeeds the signal into a processor. A mid-infrared radiation detector canmeasure the naturally emitted mid-infrared radiation from the braintunnel. A variety of detectors can be used including thermocouples,thermistors, microbolometers, liquid nitrogen cooled MTC such as byNicolet, and the like. A processor can be used to analyze and correlatethe spectral characteristics or radiation signature of the detectedmid-infrared radiation with a radiation signature of an analyte. Forglucose the generated radiation signature is within the wavelengthbetween about 8,000 nm to about 11,000 nm. The method may include ananalyzing step using algorithms based on Plank's law to correlate theradiation signature with glucose concentration. The method may furtherinclude a reporting step, such as a visual display or audio reporting.

Many illustrative embodiments for chemical sensing were provided, but itis understood that any other sensing system can be used in accordance tothe invention. For example a transducer that uses fluorescence tomeasure oxygen partial pressure, carbon dioxide, pH, nitric oxide,lactate, and anesthetic gases can also be used as well as any otheroptical chemical sensor including absorbance, reflectance, luminescence,birefringence, and the like.

FIG. 89 is a diagrammatic perspective view of another preferredembodiment showing measuring portion 2006 comprised of a plurality ofsensors and/or detectors. There is seen measuring portion 2006 having alight emitter-light detector pair 2360 and temperature sensor 2362housed in said measuring portion 2006. The radiation source-detectorpair 2360 is preferably housed in a plate 2364. Plate 2364 can have anyshape, exemplarily and preferably plate 2364 has an essentiallyrectangular shape. Rectangular plate 2364 houses at least one lightemitter 2366 in one side and at least one detector 2368 on the oppositeside. Light emitter 2366 is connected to at least one wire 2372 anddetector 2368 is connected to at least one wire 2374. Wire 2372, 2374start at the light-emitter-light detector pair 2360, and run alongmeasuring portion 2006, and terminate in multi-strand wire 2382 of arm2004. Wire portion 2382 terminates in wire portion 2384 of body 2002.Temperature sensing part 2370 is essentially cylindrical and houses wireportion 2375 (shown as broken lines) in its body 2380 and temperaturesensor 2362 located at the free end 2378 of temperature sensing part2370. Temperature sensing part 2370 is disposed adjacent to lightemitter-detector pair 2360, preferably next to light detector 2368, toavoid heat generated by light emitter 2366 to affect body temperaturemeasurement. Wire 2372, 2374, and 2376 preferably form a singlemulti-strand wire 2385 which exit measuring portion 2006. Wire portion2382 is disposed on or within arm 2004, and further disposed on orwithin body 2002. The free end 2378 of temperature sensing part 2370housing temperature sensor 2362 preferably projects beyond the bottomplane 2386 of measuring portion 2006. The temperature sensing part 2370of measuring portion 2006 can preferably comprise a soft andcompressible material. Light emitter-detector pair 2360 can also projectbeyond bottom plane 2386. Wire portion 2384 may be connected to aprocessing circuit, memory, and display and/or a transmitter. Anycombination of sensors, sensing molecules, and detectors can be housedin measuring portion 2006. Another embodiment includes a pulse sensorcombined with a temperature sensor and a glucose sensor. The measuringportion 2006 can also further include an oxygen sensor, including anoptical sensor for measuring oxygen saturation such as pulse oximetryand an electrochemical sensor for measuring partial pressure of oxygen.Any combination of any physical measurement including temperature,pressure and pulse with any chemical measurement or optical measurementcan be used and are contemplated.

FIG. 90A is a perspective planar view of another embodiment showingsensing device 2000 comprised of body 2002, arm 2004 with hole 2001 forhousing a wire, and measuring portion 2006 with hole 2003 for housing awire.

FIG. 90B is a perspective side top view of another embodiment of sensingdevice 2000 showing body 2002 having a tunnel structure 2005 for housinga wire, and arm 2004 with two holes 2007, 2009 for housing a wire, andan adjustably extendable neck portion 2011 such as an accordion portionfor allowing better flexible bending and/or extending of arm 2004 forpositioning a sensor at the BT area. Measuring portion 2006 comprises acylinder 1999 with a wire 2013 entering said cylinder 1999 and said wire2013 terminating in a sensor. Wire 2013 is preferably housed in aTeflon™ tube, said tube penetrating arm 2004 at hole 2007 adjacent tothe accordion portion 2011 and exiting at the opposite end of arm 2004at a second hole 2009.

FIG. 90C is a side view of another embodiment of sensing device 2000showing body 2002 having a tunnel structure 2005 for housing a wireportion 2015, and a thin metal sheet representing arm 2004 with said arm2004 having two holes 2007, 2009 for housing a wire portion 2017. Fortemperature measurement, measuring portion 2006 comprises a cylinder1999 of insulating material with a wire 2013 entering said cylinder 1999and running along the center of said cylinder 1999, said wire 2013terminating in a temperature sensor 2010. Wire 2017 is preferably housedin a Teflon™ tube, said tube penetrating arm 2004 in its mid portion andexiting at the end of arm 2004 at the junction with body 2002. Body 2002has two portions, a semi-rigid upper part 2019, preferably metal orplastic, and a soft bottom part 2021 made with rubber, polyurethane,polymers, or any other soft material. Wire portion 2015 runs insidetunnel 2005 of body 2002 and terminates in processing and reading unit2012.

FIG. 90D is a planar view of sensing device 2000 of FIG. 90C showingbody 2002, arm 2004 with holes 2007 and 2009 for housing a wire, saidarm 2004 having an extendable portion 2011, and a measuring portion2006.

FIG. 90E is a planar bottom view of sensing device 2000 showing body2002 having two portions, a semi-rigid upper part 2019, preferably athin sheet of metal or plastic, and a soft bottom part 2021 made withrubber, polyurethane, polymers, or any other soft material. Wire portion2017 is secured to arm 2004, said arm 2004 having an adjustablyextendable portion 2011. Measuring portion 2006 comprises a holder 1999,represented by a cylinder with a sensor 2010 disposed at the end of thecylinder 1999.

FIG. 90F is a bottom view of sensing device 2000 showing body 2002having two portions, a semi-rigid upper part 2019, preferably a thinsheet of metal, and a soft bottom part 2021 made with rubber,polyurethane, polymers, or any other soft material. Wire portion 2017 issecured to arm 2004, said arm 2004 having an adjustably extendableportion 2011. Measuring portion 2006 comprises a holder 1999 representedas a cylinder, said cylinder 1999 having a slit 2023 for facilitatingsecuring wire 2013 to said cylinder 1999, with a sensor 2010 disposed atthe end of the cylinder 1999.

FIG. 90G is illustrative of a bottom view of sensing device 2000 whichshows body 2002, arm 2004 bent for use, and measuring portion 2006having a two level insulating material 2027 of two different heights anda wire 2025 which exits body 2002. Wire in this embodiment is notexposed and is completely covered by insulating rubber in arm 2004, andby the polyurethane cylinder in measuring portion 2006, and beingsandwiched between metal plate 2019 and soft cushion pad 2021 in body2002.

FIG. 90H shows sensing device 2000 when worn by a user 2031, withmeasuring portion 2006 positioned at the junction between nose andeyebrow. Body 2002 is connected to arm 2004, said body 2002 beingsecured to the forehead 2033 via adhesive soft surface 2021.

FIG. 90I shows sensing device 2000 when worn by a user 2035, saidsensing device comprised of a plastic arm 2004 with spring capabilities,said plastic arm 2004 having a sensor 2010 at its free end positioned atthe junction between the nose and the eyebrow. Body 2002 comprises aheadband which may house an electronic circuit, processing circuit,power source, and transmitter, as well as a display.

FIG. 90J shows a two part, separable sensing device 2450 when worn by auser 2035, said two part, separable sensing device comprised of: (1) aholding device 2451 including plastic arm 2454 with spring capabilities,and (2) a patch 2462 housing a sensor 2460 with said plastic arm 2454holding said patch 2462 in a stable position for measurement. To assureeven better stability the patch 2462 may have an adhesive surface.Sensor 2460 can be placed centrically in patch 2462, and held in placeby pressure applied by arm 2454. Arm 2454 is connected to body 2452,exemplarily shown mounted on a headband 2456, but any other structuresuch as a plate, frame of eyeglasses, head mounted gear, and the like aswell as any support structures of the present invention can be used asbody 2452 connected to arm 2454. In this embodiment sensor 2460 islocated in patch 2462. Arm 2454 and body 2452 do not have any electricalparts or electronic parts, and serve as mechanical holder.Alternatively, arm 2454 and/or body 2452 may have an electricalconnector for connecting with a wire from patch 2462. Dimensions of arm2454 are similar in nature to the dimensions described for arm 2004 ofsensing device 2000. Arm 2454 helps to position patch 2462 at thejunction between nose and eyebrow. Body 2452 comprises a headband whichmay house electronic circuit, processing circuit, power source, andtransmitter, as well as a display. A cushion pad 2458 can be coupled toarm 2454 for comfort.

FIG. 91 is another embodiment showing a nose bridge or clip sensingdevice 2500 comprised of a nose bridge piece 2502, adjustablypositionable arm 2504 and measuring portion 2506. Nose bridge piece 2502preferably includes two pads 2512 and 2514 and bridge 2520 connectingthe two pads 2512, 2514, said pads preferably having an adhesivesurface. Arm 2504 branches off the nose bridge piece 2502 and terminatesin measuring portion 2506. Measuring portion 2506 illustratively isshown as a two level structure 2516 housing sensor 2510, such as a twolevel stepped “wedding cake” configuration. Arm 2504 is aimed upwards atthe roof of the orbit for positioning sensor 2510 on or adjacent to theBT. A cord or strap 2518 may be secured to nose bridge piece 2502 forbetter stability and securing to the head.

FIG. 92A to 92F shows preferred embodiments for the sensing system 2400of the present invention. Accordingly, in reference to FIG. 92A, thespecialized support and sensing structure 2400 of the present inventionincludes a body 2402 (such as frame of sunglasses, a headband, a helmet,a cap, or the like), illustrated herein as the frame of eyeglasses, forsecuring sensing system 2400 to a body part such as the head (notshown). Sensing system 2400 includes an adjustably positionable arm 2404preferably made with a shape memory alloy or any material that isdeformable and has a memory, wherein the end of this arm 2404 terminatesin a measuring portion 2406 which houses a sensor 2410 electricallyconnected to body 2402 via wire 2419. Wire portion 2418 in the measuringportion 2406 is surrounded by a compressible element 2422, preferably aspring. The spring 2422 is connected to sensor 2410. When in use thespring 2422 presses sensor 2410 against the skin creating a smallindentation. Wire 2418 terminates in wire portion 2419, and preferablytravels within arm 2404 and exits at the opposite end to connect tostructure 2402, which houses circuit board 2420 including processingcircuit 2422 and transmitter elements 2424 and power source 2421.Measuring portion 2406 preferably comprises an outer shell 2407, saidouter shell preferably comprised of a rubber like material. Sensor 2410can comprise a temperature sensor, said sensor preferably being coveredby a metal sheet, said attachment being accomplished using a thermaltransfer glue.

The eyeglasses of the present invention can include the use of acantilever system. The present invention preferably includes an arm 2404held rigidly at one end of the body 2402, represented by a frame ofeyeglasses, said arm 2404 having a free end which includes a measuringportion 2406 with walls 2407 which houses sensor 2410. The end of arm2404 can house any type of sensor or detector such as exemplarily ablood gas analyzer which includes not only a chemical sensor but also atemperature sensor as well as a heating element. It is understood that avariety of sensing systems such as optical sensing, fluorescent sensing,electrical sensing, ultrasound sensing, electrochemical sensing,chemical sensing, enzymatic sensing, piezoelectric, pressure sensing,pulse sensing, and the like can be housed at the end of arm 2404 inaccordance to the present invention. Exemplarily, but not by way oflimitation, a glucose sensing system comprised of photodetector,filters, and processor can be housed at the end of arm 2404 and operateas sensor 2410. Likewise a combination light emitter and photodetectordiametrically opposed or side-by-side and housed at the end of arm 2404to detect oxygen saturation, glucose or cholesterol by optical means andthe like is within the scope of the present invention.

FIG. 92B shows the specialized support and sensing structure 2400 ofFIG. 92A when worn by a user 2401, and comprises measuring portion 2406preferably having an essentially cone like structure positioned at thebrain tunnel 2409 at the junction of eyebrow and nose, and below theeyebrow and above the eye. Measuring portion 2406 is connected to anadjustably positionable arm 2404 which is flexible and shown in a bentposition, said arm 2404 being connected to a headband 2405, whichoperates as the body of sensing structure for securing measuring portion2406 to a body part. The center 2446 of headband 2405 has an extension2443 which houses electronic circuits, processor, power source, andwireless transmitter. Headband 2405 can function as a frame ofeyeglasses with detachable lenses.

FIG. 92C shows another embodiment of the specialized sensing eyeglasses2430 of the present invention comprised of a dual sensing system withtwo arms 2434, 2444 which branch off the upper portion 2438 of frame ofeyeglasses 2440, said arms 2434, 2444 extending from the middle portion2446 of frame 2440 and being located above the nose pads 2442. Arms2434, 2444 are located at about the middle of the frame of eyeglasses2440. Arms 2434, 2444 may include an opening for housing rods 2438,2439, said rods being connected to measuring portion 2436, 2437 and saidrods 2438, 2439 being able to slide and move within said opening in arms2434, 2444. Measuring portion 2436, 2437 houses sensor 2410, 2411 at itsexternal end, exemplarily shown as a temperature measuring sensor 2410and a pulse measuring sensor 2411. Middle portion of frame 2440 can havea receptacle area which houses power source, transmitter and processingcircuit.

FIG. 92D shows another embodiment of the specialized support and sensingstructure 2400-a of the invention and comprises frame of eyeglasses2440-a, lens 2421-a, nose pads 2423-a, adjustably positionable arm2404-a, and measuring portion 2406-a preferably having an essentiallycylindrical like structure said measuring portion 2406-a housing aspring 2422-a which is connected to sensor 2410-a. Measuring portion2406-a is connected to arm 2404-a, said arm 2404-a being connected tothe frame of eyeglasses 2440-a. Spring 2422-a projects sensor 2410-abeyond measuring portion 2406-a.

FIG. 92E is a photograph of a preferred embodiment showing a bottom viewof LED-based sensing eyeglasses 2480 comprised of a sensor 2470 inholder 2476 representing a measuring portion of sensing eyeglasses 2480,an adjustable arm 2474 branching off the frame 2477 of sensingeyeglasses 2480, LED 2478, said LED 2478 being disposed along the lensrim 2482 and above nose pad 2484, and said LED 2478 being operativelyconnected to a processor housed in frame 2477, so as to activate saidLED 2478 when the value of the biological parameter being measured fallsoutside the normal range.

FIG. 92F is a photograph of a preferred embodiment showing awireless-based sensing eyeglasses 2490 comprised of a sensor 2486 inholder 2488 representing a measuring portion of the wireless sensingeyeglasses 2490, an adjustable arm 2492 branching off the frame 2494 ofsensing eyeglasses 2490, a housing 2496, said housing 2496 extendingfrom frame 2494 and above nose pad 2498. A processor, power source, andtransmitter may be mounted inside said housing 2496 and be electricallyconnected to sensor 2486. A wireless signal corresponding to thebiological parameter measured is transmitted by a transmitter in thehousing 2496 to a receiver.

FIG. 93A shows another embodiment of the patch sensing system of theinvention. Accordingly, FIG. 93A shows a clover-leaf patch 2530comprised of two parts: (1) a thin and large flexible part in aclover-leaf shape 2522, and (2) a thicker round shaped part 2524,represented as a button, which secures a sensor 2528, said button 2524being thicker than the large underlying clover-leaf shape part 2522.Button 2524 securing sensor 2528 is attached to a thinner and large part2522. The large portion of the patch 2530 comprises the thin part 2522and the portion of the patch 2530 holding the sensor 2528 comprises apart of smaller size as compared to the thin part 2522. The portionholding the sensor 2528 is smaller and thicker than the underlyingportion of the patch 2530. Large part 2522 is thinner and larger in sizethan said portion holding the sensor 2500. The sensor 2528 is connectedto a wire 2526 which has an approximate 90 degree bend between the sideportion of button 2524 and the plane of the large portion 2522. Wire2526 runs along the button 2524 and then runs along the thin portion2522, and exits the thin portion 2522. The button 2524 holding thesensor 2528 projects beyond the surface of the thin portion 2522, saidbutton 2524 being preferably eccentrically positioned on the thinunderlying portion 2524 of patch 2530. Both the thin portion 2522 andthe thick portion 2524 of patch 2530 may have an adhesive surface on thesurface of the patch 2530 facing a body part.

FIG. 94A to 94B shows an illustration of another embodiment of thesupport structure or sensing system 2540 of the invention, for use inanimals, with sensor 2550 placed on the eyelid area 2538 of an animal2536 at the brain tunnel 2532. The animal BTT sensing device 2540includes a body 2542, represented by a plate, an adjustably positionableelongated arm 2544 attached to said plate 2542, and a sensor 2550disposed at the free end of said arm 2544. Arm 2544 is secured to plate2542, said arm 2544 preferably having a sliding mechanism and plate 2542preferably having a groove 2552, allowing thus arm 2544 to move inrelation to plate 2542 so as to position sensor 2550 on the BTT area2532 while plate 2542 is in a fixed position on the skin of animal 2536.Grooved mechanism 2552 has a plurality of locking positions, allowingarm 2544 to be locked in different positions. Arm 2544 is connected to aprocessing and transmitter unit (not shown) through wire 2546. Sensor2550 has preferably an essentially rectangular shape. Preferably sensor2550, or the material surrounding sensor 2550 such as epoxy, has athickness between 1 mm and 6 mm, and most preferably a thickness between2 mm and 4 mm, and most preferably a thickness between 1 mm and 3 mm.Sensor 2550 can be covered by insulating material or any material thatpresses the sensor 2550 leading the sensor to enter the brain tunnel,said other materials can thus increase the overall thickness of thesensor portion.

It is understood that plate 2542 can work as a circuit board and house aprocessor, wireless transmitter and power source. Alternatively, plate2542 houses a transmitter and power source with signals beingtransmitted to a remote receiver for further processing and display ofresults, or plate 2542 holds an antenna for remote electromagneticpowering including passive devices. It is understood that theelectronics, transmitter, processor and power source can be housed in abox for implantation under the skin of the animal. In this embodimentthe plate 2542 is replaced by this box, and the method includes the stepof creating an opening on the skin, and implanting the box under theskin or on top of the skin while arm 2544 preferably remains on top ofthe skin, and said box is anchored under the skin. A further step mayinclude suturing the skin around the sensor 2550 in order to providebetter stability and protection of the sensor, with said suture graspingthe skin 2554 on the upper part of brain tunnel 2532 and the skin 2556in the lower part of brain tunnel 2532, and applying a stitch on edge ofeach said skin 2554, 2556, said stitch located right above sensor 2550.

FIG. 94B shows another embodiment for animal sensing device 2540,comprised of a multi-layer protection cover 2558 which is mounted on topof the plate 2542 and the sensor (not shown since it is covered by layer2558), said layer 2558 preferably having insulating properties, an arm2544, and a wire 2546. Preferably a thick support such as hard piece ofmaterial such as wood in the shape of the sensor is placed on top ofsaid sensor for creating better apposition between sensor and the skinat the BTT.

The method includes securing plate 2542 to the head of a mammal,preferably by gluing the internal surface of the plate 2542 to the skinof the animal using glue or an adhesive surface; positioning sensor 2550on the BTT 2532 at the eyelid area 2538, said step preferablyaccomplished by sliding arm 2544 in a groove 2552 in plate 2542 untilthe sensor 2550 is on or adjacent to the BTT area 2532. A further stepmay include bending the free end of arm 2544 and applying pressure atthe BTT 2532 by sensor 2550 and producing a signal by said sensor 2550.Further steps include applying an electrical current, and generating asignal by sensor 2550. Other steps may include processing and analyzingsaid signal, and reporting a value of said signal. Similar steps can beused when applying sensing device 2000, but preferably during humanmedical use positioning may not include a sliding step.

Now in reference to FIG. 95A, there is seen another method and apparatusof the invention, comprised of coupling signals from a physiologicaltunnel, such as for example, coupling the BTT signal with alert meansmounted on apparel, such as clothing, or coupled with footwear. Itshould be understood that any article of footwear including sneakers,cleats, sports shoes, sandals, boots, and the like is considered withinthe scope of this invention as well as any type of apparel or clothing.

Prior art relied on numerical values for guiding a user about exerciseintensity, such as looking at a wrist watch to see the value for heartrate from a chest strap monitoring heart beat. Looking at a number hasseveral disadvantages including increasing stress and distraction, bothof which can lead to reduced performance. In addition, the human brainis organized in a way to associate indicia such as numbers with aparticular information or condition, and that may briefly reduceconcentration in the exercise in order for the brain to finish theassociation, which in this case is for example number 100 beats perminute (bpm) means out of an optimal pulse zone for fitness or number39.5 degrees Celsius meaning out of optimal thermal zone. Just holdingthe arm to look at a number may take away precious seconds ofperformance, since to see a number is necessary to use the ciliarymuscle of the eye to focus and also to hold the display in a essentiallymotionless position such as holding the arm steady and aligned with theeye. In addition, a person older than 45 years of age may havepresbyopia and thus have difficult seeing a numerical value unless usingeyeglasses. Contrary to those disadvantages of the prior art, thepresent invention relies on reporting means which do not require usingthe ciliary muscle of the eye to focus such as in order to read anumber. The present invention also is suitable for use by persons of allages including people older than 45 years of age and with presbyopia andeven cataract. In addition the present invention does not requireholding a display in an essentially immobile position. Actuallyreporting means of the present invention are preferably in constantmotion during the time of providing the information to the user.Furthermore there is no distraction as trying to read a number andassociate that number with a biological condition. Furthermore there isno increased stress as occur when looking and seeing a numerical value,nor extra brain work to interpret a number. All of those advantages areaccomplished by using a light source as the reporting means, as inaccordance with this invention, said light source adapted to provideinformation according to the value of the biological parameter. Inaddition, a light source, such as in a shoe, is naturally present withinthe visual field of a human without said subject having to directly lookor focus at the light. This allows the information to be naturallydelivered and effortlessly received by the user. Furthermore the brainthrough the occipital cortex is better adapted to recognize a visualstimulus than a numerical stimulus and the brain is also better adaptedto memorize visual stimuli such as a yellow LED to inform aboutpotential danger than to memorize a number such as 147 bpm or 38.9degrees Celsius. Furthermore, the information such as a light source isavailable immediately and without the need for association as occurswith numbers. In addition, the human brain is trained on a daily basisfor recognizing and processing visual stimuli, such as green, yellow andred lights in a traffic light or the LED of an electronic device toindicate the device is turned on. Accordingly, the present inventioncouples the biological aspects related to visual stimuli withengineering and discloses such monitoring device, which preferableinclude LEDs mounted on or in a wearable article such as clothing,apparel accessories, or shoes as the reporting means instead ofnumerical values.

FIG. 95A illustrates coupling of physiological signals such astemperature and pulse with footwear, said footwear operating as areceiver for the signal and to alert the user of abnormal physiologicalvalues. This embodiment is directed to an article of footwear having oneor a plurality of alert means such as light sources, represented byLEDs, vibration, buzzers, speakers and the like, which are activatedaccording to the physiological value measured by a sensor. It isunderstood that any sound can be produced or any visual indicia can beused to effortlessly and naturally inform the user about the biologicalparameter level without the need to display any numerical value orrequiring the user to look for the information such as for examplelooking at a watch. The information is acquired by the user in a passiveand effortless manner. The visual field of a user allows receiving thevisual stimulus without having to do any extra movement such as holdingthe arm to look at a watch. The actual numerical value during physicalexercise is of secondary interest since the key aspect for evaluatingexercise level is a range of values or threshold values, (such as toohigh or too low) which are represented by visual and sound stimuli, asper the present invention. By causing a light to be illuminatedcorresponding to the value of a biological parameter, the user isassisted in guiding the exercise level and remaining within safe zones,in an effortless way in which the user has immediate response withouthaving to think about a number being displayed and then analyzingwhether the number falls into a desired exercise level.

Besides temperature and pulse, any other signal can be used includingoxygen level, blood pressure, glucose level, eye pressure, and the likeas well as signals from other devices such as a pedometer and the like.In addition, the light-based reporting means of the invention caninclude activation of a light source, such as LED, to indicate thedistance or in the case of speedometer to indicate the speed of theuser. For example, a user can program the pedometer to activate a lightevery 1,000 steps or every mile for instance during a marathon. Theprogram is also adapted to activate a LED when the user is runningwithin a certain speed, said speed being predetermined by the user. Inthis embodiment for example, the pedometer has 3 LEDs blue, green, andred, which are programmed to be activated according to a predeterminedspeed or distance. For example, the blue LED is activated if the speedis less than 6 minutes per mile, the green LED is activated if the speedis between 6 and 7 miles per minute, and the red LED is activated if thespeed is more than 7 miles per minute. The system may also include aglobal positioning system or other system to track speed and/ordistance, with a light being activated when the desired speed ordistance is achieved, or alternatively the light is activated when theprogrammed speed and/or distance is not achieved.

The alert means alert the user when the signals received from a sensorare within appropriate levels or alert the user when the signal isoutside levels of safety. For example, alert means inform the user aboutsaid user being in an optimal thermal zone (OTZ), in which the bodytemperature is within ideal levels for example for stimulating formationof heat-shock proteins. The OTZ is considered an appropriate level forhealth and performance, such as a temperature range between 37.0 degreesC. and 39.4 degrees C., and most preferably around 38.0 degrees C., andeven more preferably around 38.5 degrees, up to 39 degrees C., forstimulating formation of heat shock proteins. The OTZ indicates a rangeof temperature that is safe and that leads to the best performancewithout overheating. Different levels of OTZ can lead to burning fatefficiently, as burning generates heat which is reflected in an increasein body temperature. Likewise, an optimal pulse zone (OPZ) indicates theoptimal range for improving heart fitness. A second zone OPZ-F indicatesthe range of pulse that can lead to burning fat. A variety of optimalzones can be used and programmed so as to activate the LEDs inaccordance with the optimal zone of interest such as fitness, endurance,heart-lung exercise, improving cardiovascular fitness, burning fat, andthe like.

The alert means of the footwear or clothing preferably includes a set oflights which are activated according to the level of a biologicalparameter, such as temperature zone or pulse of the user. One aspect ofthis invention includes providing an interactive footwear or apparelwhich helps the user maintain physical activity within an optimal rangeby visualizing lights and/or listening to sound from shoes and/orapparel. An array of LEDs are mounted on a portion of footwear orclothing which are easily visualized, such as for example the upperportion of a footwear or the portion of an apparel covering the chest orfront part of the lower extremities. It is understood that any headmounted gear can also be used with the array of LEDs mounted on alocation easily visualized during physical activity. The informationabout exercise level is then acquired in an effortless way and a naturalway. A particular number is not necessary in the preferred embodiment,since the array of lights can indicate the level of exertion and whetherthe user is within an optimal zone for the planned activity. For examplean array of LEDs mounted in the tongue of a shoe or upper portion of ashoe illuminates in a certain manner or flashes in a sequence toindicate the level of a biological parameter, such as pulse level,oxygen level, blood pressure level, or temperature level, or to identifythe presence of a chemical substance such as drugs or any analytepresent in the body.

In one embodiment an array of LEDs is mounted on the upper portion ortongue of the shoe, said LEDs being electrically connected to aprocessor which controls and drives the LED array based on an electricalsignal, received from a transmitter coupled to a sensor monitoring aphysiological parameter. The processor is operatively coupled to areceiver, said receiver receiving signals from said sensor monitoring aany parameter including physiological parameters or environmentalparameters such as ambient temperature, humidity, wind and the like,said signals from said sensor preferably being wirelessly transmitted tothe receiver in the footwear. In another embodiment the sensor islocated in the shoe including sensors for physiological parameters suchblood flow, temperature, pulse and any other physiological parameterand/or for detecting ambient conditions such as a ambient temperature,humidity, ultraviolet rays, wind, and the like. In those embodimentsthere is no need for signal transmission as with remotely placed sensorssince the light source is also located in the shoe, and said lightsource can be integrated with the sensor. The processor is operative toilluminate the LED for a certain period of time preferably in accordancewith the user being in the OTZ and/or OPZ, for example by illuminating agreen LED. Alternatively, the processing circuit illuminates a red LEDto inform the user that the temperature or pulse is too high, or a blueLED to inform that the temperature or pulse is too low, or anycombination thereof involving any color or number of LEDs.

The signal from the transmitter coupled to the sensor is transmitted tothe receiver in a shoe or clothing, said signal driving a LED or aspeaker in said shoe or clothing. For example, when a human subjectmonitoring pulse and temperature with a BTT sunglasses sends a wirelesssignal from said BTT sunglasses to a receiver in a shoe worn by saiduser, and said signal corresponds to an optimal thermal zone and optimalpulse zone, then said signal causes two green LEDs to illuminate in theshoe to indicate that both temperature and pulse are within ideallevels, and causes the shoe to produce the sound “optimal zone”. It isunderstood that any sound can be produced or any visual indicia can beused to effortlessly and naturally inform the user about the biologicalparameter level. Accordingly, if the signal received indicates the useris too hot or the pulse is too high, then an indicia representing aCoca-Cola™ logo or a Pepsi-Cola™ logo is illuminated indicating that theuser should take some liquid and be hydrated, so as for example to avoidheat injury. Likewise, the signal indicating high temperature can causethe speaker in the shoe or apparel to produce the sound “water”, “timefor your Coke™”, “time for your Pepsi™”, and the like. Besidesmonitoring pulse with a BTT device, any other device for pulse detectionincluding a conventional chest strap for pulse monitoring can be used,said monitoring devices transmitting a signal to a shoe or apparel todrive lights, speaker, and the like. It is also understood that anysignal from any device monitoring physiological parameters can be used.Accordingly, a device monitoring glucose, eye pressure, drug levels,cholesterol, and the like can transmit the signal to a footwear orapparel, which cause for example a LED representing low glucose levelsto illuminate, and the speaker to produce the sound “sugar low—drink ajuice” or the name of a medication is illuminated in the shoe or apparelto indicate the physiological value. Thus when a diabetic is the user ofthe biological light-sound system of this invention and if the user ismonitoring glucose and the word “insulin” is illuminated in the shoe,clothing, or accessories, then that user knows that sugar levels are toohigh.

It is understood that the housing, referred to herein as module orbiological monitoring electronic-LED module, containing the RF receiver,power source, processor, LED, and speaker can be removably attached tothe shoe or apparel or permanently mounted on the shoe or apparel. Forexample a pocket in the shoe or apparel such as a pocket in the tongueof the shoe can be used to house the biological monitoringelectronic-LED module. Any pocket or other means to secure one or aplurality of modules to a shoe or apparel are contemplated and can beused. For example, two modules, one for monitoring temperature from aBTT sunglasses is secured by a hook and loop fastener (such as aVelcro™) to a shirt while a second module for monitoring pulse from achest strap is placed in a pocket located in the tongue of a shoe. Whenthe BTT sunglasses sends a temperature signal to inform the user of thetemperature level the LED secured to the shirt illuminates. The sameoccurs with the LED in the shoe which is activated by a pulse signalfrom the chest strap.

Now referring to FIG. 95A, there is seen a shoe 2600 having an upperportion 2602 including a tongue 2604 having a housing 2606, such as apocket, for housing module 2610, said module 2610 including a powersource 2612, a wireless receiver circuit 2614, and at least one LED 2620operatively coupled to the wireless receiver circuit 2614 functioning asa LED driver. Module 2610 can further include a processor 2616 and aspeaker 2618. Module 2610 is preferably made of plastic or anywater-proof material. Although module 2610 is shown mounted in a tongue2604 of the shoe 2600, it is understood that module 2610 can be mountedon any part of any shoe and in any type of shoe. It is furtherunderstood that module 2610 can include electronics mounted in onelocation of the shoe connected to a fiber optic or LED mounted in asecond location in the shoe. For example the battery, wireless receiver,and controller are housed in a cavity in the heel of the shoe, and saidelectronics and battery in the heel are connected through wires to a LEDin the tongue of the shoe, or an electronic circuit in the sole of theshoe can be connected to fiber optics located in the front part of theshoe. Any type of light source can be used including LED, fiber optic,chemiluminescent sources such as a light stick, fluorescent light, andthe like. The location of the light source and speakers include anyportion of the apparel or shoe, preferably the light source is locatedwithin the natural visual field of a human. It is understood that all ofthe arrangements described for a shoe can be used for an apparel orclothing.

The module 2610 can include a switch 2622, which can be activated byapplication of pressure when the shoe is in use or the module 2610 caninclude a manually operated switch. Module 2610 can include any type ofinertia-based switch to allow automated activation of a receiving systemof module 2610. Accordingly, when the shoe is not in use or nopressure-based switch is activating the receiving system of the shoe itautomatically shuts off. In addition, if the receiving system of theshoe does not receive any signal for a certain period of time, such asfor example 10 minutes, then the receiving system of the shoe alsoautomatically shuts off. Those arrangements for automatically turningthe shoe on and/or off allows saving battery power and/or making thesystem of this invention easier to use. If the user wants to know anactual number for the biological parameter, a switch located in themonitoring device coupled to the sensor can be activated or a secondswitch on the shoe or apparel can be activated and a number can bedisplayed in the shoe or apparel, or in the monitoring device. In thisembodiment, the shoe or apparel, or monitoring device can include anumerical display. For example, it is contemplated that the BTTsunglasses can be adapted to display a numerical value on the lens ifrequested by the user.

In FIG. 95B-1, a schematic illustration of this invention for pulse andtemperature measurement is shown and includes a heart rate monitoringdevice 2624, represented by a chest strap for detecting a heart beat, athermometer 2626, represented by eyeglasses for detecting bodytemperature, and a shoe, 2630, said shoe 2630 having a logo 2628comprised of LEDs. Logo 2628 is seen in a magnified view in FIG. 95B-2,which shows one first LED 2632 and a second LED 2634 corresponding to aheart zone, said first LED 2632 being coupled to a signal representing aslow heart rate, and said second LED 2634 being coupled to a signalrepresenting a fast heart rate. Besides LEDs 2632, 2634 coupled to aheart monitoring zone, a third LED 2636 corresponds to a bodytemperature zone, said LED 2636 being coupled to a signal representingan unsafe temperature level, such as a high body temperature.

Several exercise programs can be implemented with the invention. Inorder to achieve the proper exercise intensity, the user can use keypadsor buttons to enter information into the monitoring device such as theeyeglasses or the chest strap device, or alternatively the user canenter the information in the shoe, said shoe being adapted to receiveinformation and said information including age, body weight, height,exercise goals, and the like. A processor can then calculate the optimaltemperature zone and optimal pulse zone for that particular exercisegoal which will activate the LEDs in accordance with the signal receivedand exercise goal. For example, a user 40 years of age, 1.80 m tall, andweighing 95 kg, who wants to have a long workout (more than 45 min) withthe objective of burning fat (weight loss), enters the information,which is fed into a processor. The processor is operatively coupled to amemory which stores the OTZ and OPZ associated with an exercise goal anduser data. For example according to the user data, OTZ is between 38.1degrees Celsius and 38.5 degrees Celsius and the OPZ is between 117 and135 beats per minute (bpm), meaning optimal pulse is between 117 and 135bpm. A preferred way to calculate the OPZ includes subtracting 220 fromthe age, which provides 180, and then calculating a percentage of theOPZ number (180) based on the user and exercise goals, which in thisexample is between 65% and 75%.

The processor is operatively coupled to the LEDs, and in the exemplaryembodiment if the temperature signal from the thermometer eyeglasses2626 corresponds to a temperature higher then 38.5 degrees then LED 2636is illuminated to indicate the high temperature, translating for exampleinto the need for hydration or reducing exercise intensity since theuser is outside his/her OTZ. Likewise, if a pulse signal from heartmonitoring device 2624 corresponds to a heart rate less than 117 beatsper minute, which is the target for the slowest heart rate, then theprocessor activates LED 2632 which is illuminated and indicatingtherefore a slow heart rate for the exercise goal. If the signalreceived from heart monitoring device 2624 corresponds to a heart ratefaster than 135 bpm, which is the target for the fastest heart rate,then LED 2636 is activated and illuminated.

Considering another embodiment with four LEDs comprised of two LEDsmarked T and two LEDs marked P, if the temperature falls below 38.1degrees Celsius a “yellow LED market T” is illuminated indicating lowtemperature for OTZ, and if above 38.5 degrees Celsius then a “red LEDmarked T” is illuminated. If pulse is slower than 117 bpm then “yellowLED marked P” is illuminated and if pulse is faster than 135 a “red LEDmarked P” is illuminated.

An exemplary algorithm for heart monitoring in accordance with thisinvention is seen in FIG. 95C-1 and includes step 2640 to “acquire heartrate signal”, which is preferably received wirelessly from heartmonitoring device 2624. Step 2642 then determines whether “heart rate isslower than the slowest target heart rate”, illustrated in theembodiment as heart rate less than 117 bpm. If yes, then step 2644activates LED 2632 to indicate slow heart rate, and then proceed withthe program at step 2640 to acquire heart rate signal. If not, then step2646 determines whether “heart rate is faster than the fastest targetheart rate” illustrated in the embodiment as a heart rate faster than135 bpm. If yes, then step 2648 activates LED 2634 to indicate a fastheart rate and then proceed to step 2640. If not, then processingcontinues and program proceeds to step 2640. Likewise, FIG. 95C-2 showsan algorithm for body temperature monitoring according to thisinvention. Step 2650 acquires body temperature level, and step 2652determines whether “temperature is higher than the highest targettemperature”, illustrated in the embodiment as temperature more than38.5 degrees C. If yes, then step 2654 activates LED 2636 to indicate ahigh temperature and then proceed to step 2650. If not, then programcontinues to step 2650 and processing continues.

The invention includes a method for detecting and transmitting abiological parameter, receiving the transmitted signal with a receiverconnected to a shoe or apparel, processing the received signal,determining the value of the biological parameter, and activating alight source based on the value. Further step may include activating aspeaker. Other steps may include displaying a numerical value andtransmitting the signal to another device.

It is understood that the program can be done in sequence, and includeother parameters such as oxygen level and uptake, glucose level, bloodpressure, acid lactic level, heat shock protein, and any otherbiological parameter or environmental parameter such as ambienttemperature, humidity, wind speed, and the like. All of those parametersare reported using the reporting means of the invention such as the LEDsystem of the invention. Accordingly, in yet another embodiment of thisinvention, a plurality of array of LEDs are provided. For example afirst array of LEDs detects one parameter (e.g. pulse), said array ofLEDs separate from a second array of LED measuring a second parameter(e.g. temperature), and both the first and second array of LEDs beingseparate from a third array of LEDs which measure a third parameter(e.g. environmental humidity). Each group of LEDs can be activated by asignal from a separate transmitter connected to each specific array ofLEDs.

It is also understood that each LED can be marked with indiciaindicating the physiological condition. Accordingly, an LED can have forexample wording “High Temp”, and/or “Fast HR” and/or “Slow HR” in orderto report the physiological condition. Furthermore, a speaker or speechsynthesizer can be included and concomitantly activated to produce, forexample, the sound “High Temp”, and/or “Fast HR” and/or “Slow HR”. It isalso understood that LED of different colors to indicate differentlevels for biological parameters can be used. For example, a green LEDrepresents heart rate less than 130 bpm, a yellow LED represents heartrate more than 130 but less than 170 bpm, and red LED represents heartrate more than 170 bpm. A series of bars can also be used, one barilluminated indicating heart rate less than 130 bpm, two barsilluminated indicating heart rate less than 170 bpm, and three barsilluminated indicating heart rate more than 170 bpm. The inventionfurther includes a kit containing a device to monitor biologicalparameter and a shoe or an apparel. The kit can further includeinstructions. The illuminating device, such as LED, can be alsoremovable to permit interchangeable selectivity of the color of theilluminating light.

Referring now to FIG. 95D, a block diagram is schematically illustrated,which includes a BTT transmitting system 2656, a heart rate transmittingsystem 2658, and shoe receiving system 2660. BTT transmitting system2656 includes a BTT sensor 2662 (such as a temperature sensor), aprocessor and processing circuit 2664 including temperature algorithms,a transmitter 2666, an antenna 2668, and a battery 2670. Heart ratetransmitting system 2658 includes a heart rate sensor 2672, a processorand processing circuit 2674 including heart rate algorithms, atransmitter 2676, an antenna 2678, and a battery 2680. Heart ratetransmitting system 2658 can include a system comprised of electrodesand a transmitter attached to the body of the user, which can be housedfor example in a chest strap. Heart rate monitoring system 2658 can alsoinclude a wrist band, headband, head mounted gear, or any other means tomonitor pulse or gear adapted to detect a pulse of a user. Shoereceiving system 2660 includes a receiver 2682 a processor and displaycontrol circuit 2684, an antenna 2686, and LEDs 2688, 2690, 2692, saidLEDs 2688, 2690, 2692, corresponding to a different physiologicalcondition as previously described. Accordingly, LEDs 2688, 2690, 2692,can correspond to the functions of LEDs 2632, 2634, and 2636. It isunderstood that each of the systems 2656, 2658, 2660 can includeswitches, electrical connections, and other integrated circuits forperforming the need functions. Sensors 2662, 2672 generate an electricalsignal which is transmitted to shoe receiving system 2660. In responseto the signal received from the transmitting systems 2666, 2676 theprocessor and display control circuit 2684 may activate one or more LEDsfor a certain period of time including flashing. Essentially anycombination of lighting sequences of the LEDs and flashing can beemployed in response to a signal received. The system of the inventionprovides a novel way in which a biological parameter level is indicatedthrough illuminating specific LEDs. By causing a light to be illuminatedcorresponding to the value of a biological parameter, the user isassisted in guiding the exercise level and remaining within safe zones,in an effortless way in which the user has immediate response withouthaving to think about a number being displayed and then analyzingwhether the number falls into a desired exercise level and/or safelevel.

It is understood that other receiving devices are contemplated and canbenefit from the present invention. For example, an exercise machine canreceive the signal and an array of LEDs mounted in said machine indicateto the user the exercise condition and biological parameter valueswithout the user having to rely on a numerical value. Other devicescontemplated include a wrist band mounted with at least one LED which isactivated based on the level of the biological parameter, said wristband detecting the level and reporting the level through a least oneLED. In this embodiment there is no need for wireless transmission sincethe wrist band can detect pulse and thus detecting and reportingfunction are accomplished in the same device. Likewise, a chest strapcan have one or more light sources to indicate the pulse level, saidchest strap preferably being part of a garment or being under a thinshirt to facilitate visualizing the flashing LEDs. In another embodimentthe chest strap monitoring heart rate can include speaker for audioreporting of a numerical value or reporting an optimal zone forexercising such as OPZ or OTZ. It is also understood that a wrist watchcan include a set of lights which are illuminated to indicate OPZ andOTZ, or any other optimal value of a biological parameter. Besides, arange and threshold, a mean value can also be calculated and an LEDactivated to indicate achieving that mean value, or being outside themean value, such as for example a mean pulse value. It is understoodthat in addition to illuminating light for feedback, if the userchooses, real-time, spoken feedback can alert said user to milestones,such as number of miles, throughout a workout. It is also contemplatedthat the shoe or apparel may include a chip that recognizes module 2610,which can work as a removably attached module, so a user can removemodule 2610 from one shoe and insert the same module 2610 in or on anapparel or in or on another shoe, so any shoe or apparel with the chipcan use the module 2610.

There are basically two types of thermometer probes using contactsensors in the prior art: 1) one for measuring internal temperature suchas food thermometers and body temperature such as oral thermometers,which are inserted inside the object being measured, and 2) a second onefor measuring surface temperature, such as for instance measuringtemperature of a grill. Contrary to the prior art this invention teachesa new method and apparatus which combines in the same thermometer probefeatures of both internal temperature measurement and surfacetemperature measurement, such arrangement being necessary for measuringtemperature in the brain tunnel.

Thermometer probes for internal temperature measurement of the priorart, such as oral/rectal thermometers, have temperature sensors coveredby a metal cap or by other materials which are good heat conductors. Thetip of the thermometers of the prior art were made out of metal or otherthermally conducting material such as ceramics and the like, includingthe temperature sensor on the tip being surrounded by a metallic cap.Contrary to the prior art, this invention teaches a thermometer in whichthe temperature sensor is surrounded by an insulating material. Indistinction to the prior art, the thermometer of this inventioncomprises a tip in which there is no metal or any conducting materialsurrounding the temperature sensor. The sides of the tip of thethermometer of this invention comprise insulating material, and thus thesides of the tip have at least one insulating layer. In addition thisinvention couples specialized dimensions with a novel temperaturesensing tip that includes an insulating tip instead of a metallic tip,said insulating tip housing the temperature sensor.

Thermometer probes measuring surface temperature are concerned only withthe surface being measured and thus do not require insulation in a largearea of the probe nor a metallic cover to increase heat transfer.Basically those surface thermometer probes of the prior art have athermocouple at the end of the probe, said end being rigid and made withhard material.

The design of this invention allows both to be accomplished, measuringinternal as well as surface temperature simultaneously. In order toachieve precise surface measurement the BTT sensor is completelysurrounded by insulation at the end of the probe. In order to measureinternal temperature, the sensor has to enter the tunnel which causes anindentation in the skin. When the probe is pushed into the tunnelbecause of the characteristics of the BTT area and of skin, there is arather significant indentation, which leads the skin to encircle andsurround the tip, which would lead to affecting the temperature of thethermal sensor since the skin is cold. To prevent that, the probe of theinvention has a rather long area (length) of insulating material abovethe sensor, and no heat conducting material around the tip of the probe,besides the special dimensions previously described. In addition, toconform to the specialized geometry of the skin at the BTT, theinsulating material of this invention comprises a soft and preferablycompressible insulating material at the tip. Contrary to this invention,the prior art has used hard materials on the tip, since those probes areused for measuring hard and/or flat surfaces, and not irregular surfacessuch as the skin at the BTT. In addition, since the BTT geometry isconcave in nature, the preferred embodiment of the end of the probe ofthis invention is essentially convex. Furthermore, the tip of the probemay comprise one or more sensors, and preferably a plurality of sensorsdisposed in an essentially convex surface. Programming in the processorselects the highest temperature among all sensors facilitating readingthe temperature at the main entry point of the tunnel, which has thehighest temperature. Preferably, a tip of the probe or the measuringsurface of the probe includes both sensor and insulating material insaid surface, and said probe is essentially cylindrical. The sensor ofthis invention which is located at the tip of the probe is surrounded byinsulating material, both on top of said sensor and around the sides ofsaid sensor. The sensor of this invention is preferably exposed at thetip of the probe without any material covering said sensor. Contrary tohard insulating material of the prior art, the sensor of this inventionis surrounded by soft insulating material. The probe preferably uses arod and hand held configuration. Contrary to the prior art which useshard material to support the tip of the probe, such as used in surfacemeasuring thermometer, the present invention uses exclusively softmaterial around the thermal sensor in its entirety, and no metallic orhard material are adjacent to the sensor or located within 4 mm from thetip of the sensor, this material being illustratively represented inseveral embodiments including body 2020. The shape of the tip of theprobe of this invention is designed to conform and take the shape of thearea of the BTT below and adjacent to the eyebrow and the nose, and morespecifically to match the roof of the orbit by the nose and eyelid area.The prior art has a very small amount of insulating material around thetip since it was not designed to measure internal temperature. Contraryto the prior art, this invention, by having the necessity of avoidingtemperature of the skin that may encircle the probe during entry of thesensor into the tunnel affecting the measurement, a rather large amountof insulation is used. The preferred length of material at the tip ofthe probe, said insulating material facing the environment, is equal toor less than 3.5 mm, and preferably equal to or no greater than 5 mm,and most preferably equal to or no greater than 10 mm. The insulatingmaterial at the tip is preferably not covered by any other material. Thethermometer probe of this invention uniquely has features of both typesof thermometer, penetrating and surface measuring thermometers. The tipof the thermometer of this invention preferably uses deformable materialand conforms to the surface being measured. The tip of the probe takesthe contour of the area that is being measured so it seal off anyambient temperature, and prevent surrounding skin tissue around thetunnel from touching the temperature element. Preferably stand aloneinsulating material is what supports the tip of the probe, said materialbeing preferably compressible material with some springingcharacteristics. Features mentioned herein have been described inseveral embodiments of this invention including measuring portion andFIG. 96V-l to FIG. 97M-2.

In addition, the present invention discloses novel methods and apparatusfor measuring biological parameters, such as temperature. Accordinglyand in reference to FIG. 96, the present invention discloses anintelligent stylus 2700 associated with an electronic device 2702, suchas a PDA, a hand held computerized device, a tablet computer, a notebookcomputer, or any electronic device which uses a rod (stylus) fortouching the screen for performing a function. The device of theinvention includes the intelligent stylus 2700 represented herein by atouch-screen stylus or any rod for touching the screen of the electronicdevice 2702. Stylus 2700 houses a sensor 2704 on one end 2706, said endbeing opposite to the end of the stylus adapted to touch the screen,with said end 2706 referred herein as the sensing end of stylus 2700,and further including an opposite end 2708, hereinafter referred to asthe touching end of the stylus 2700. Stylus 2700 further includes wiring2710 disposed on or inside stylus 2700, and preferably inside the body2712 of the stylus 2700 for connecting said stylus 2700 with electronicdevice 2702. The free end of wire 2710 connects with sensor 2704 and theother end exits the stylus 2700, and connects with a thicker externalwire portion 2714 which is connected to electronic device 2702. Wire2710 preferably exits said stylus 2700 at the mid portion 2716. In theprior art, wires exit a rod through the end or the tip of said rod, andnot through the mid-portion of the rod. This novel arrangement of thepresent invention which include the wire exiting in the middle portionof the rod, allows both ends, sensing end 2706 and touch screen end 2708to be free, with the touching end 2708 for touching the screen 2718 ofelectronic device 2702 and sensing end 2706 housing sensor 2704 to touchthe body for measurement.

The electronic device 2702 comprises a touch-screen 2718 which includesa display box 2720 for displaying the numerical value of the signalacquired by the sensor 2704, a second window 2722 to display storedvalues of the signal being measured, a wire 2714 for connecting theelectronic device 2702 with the stylus 2700, and further preferablyincluding a dialog box 2724 for displaying user information such aspatient identification, in addition to a processor 2726, and powersource 2728. If electronic device 2702 is arranged as a Personal DigitalAssistant (PDA), it preferably includes a conventional key pad 2730 forPDAs.

FIG. 96A concerns Prior Art and shows a rod 2732 with a contact sensingtip 2734 for body temperature measuring device, such as internalthermometer, with said sensing tip 2734 comprised of metal or othermaterial with high thermal conductive. Sensor 2745 in the tip 2734 ofrod 2732 is covered by a high thermal conductivity material 2735. Tip2734 of the prior art also comprises a hard material. In addition thetip of a thermometer of the prior art covered by metal or a thermallyconductive material has a dimension equal to or more than 10 mm for saidthermal conductive material.

In contrast to the Prior Art, FIG. 96B shows the specialized temperaturemeasuring device 2760 of this invention, wherein a rod 2742 with asensing tip 2740 housing a temperature sensor 2736 is surrounded by aninsulating material 2738, said insulating material 2738 comprised of anymaterial having low thermal conductivity. Rod 2742 is connected to amain body 2752, said body 2752 housing a printed circuit board withmicroprocessor 2754, battery 2756 and display 2758. The tip 2740 housingthe temperature sensor comprises low thermal conductivity material 2738.The tip 2740 of the rod of the thermometer of this invention includes acombination of a temperature sensor 2736 and low thermal conductivitymaterial 2738. Temperature sensor 2736 is surrounded by insulatingmaterial 2738, with only the sensing surface 2746 of said sensor 2736not being covered by insulating material 2738. The external sidesurfaces 2744 of the tip 2740 comprise insulating material 2738.Temperature sensor 2736 is surrounded by the insulating material 2738.The insulating material 2738 has an external sensing surface 2748 whichtouches the body or skin during measurement and supports the sensor2736, an external side surface 2744 which is essentially perpendicularto sensing surface 2748, and an internal surface 2750 which faces theinner portion of the rod 2742. FIG. 96-C is a schematic perspective viewof the tip 2740 of the rod 2742 of FIG. 96-B showing sensor 2736 and theinsulating material 2738, said insulating material 2738 having externalsensing surface 2748 and side external face 2744. The preferred largestdimension for external sensing surface 2748 of insulating material 2738is equal to or less than 20 mm, and preferably equal to or less than 15mm, and most preferably equal to or less than 10 mm in its longestdimension, and even most preferably equal to or less than 8 mm. Thepreferred largest dimension of the temperature sensor 2736 is equal toor less than 6 mm, and preferably equal to or less than 4 mm, and mostpreferably equal to or less than 2 mm in its longest dimension, and evenmost preferably equal to or less than 1 mm, in accordance to the mainentry point and general entry point, of the brain tunnel. The dimensionfor other sensors are similar, such as pressure, piezoelectric, and thelike, and a pair light emitter-detector may include larger dimensions.Dimensions of and description of insulating material is applicable toany of the rod-like embodiments of this invention including intelligentstylus 2700, and any other rod-like sensing device such as a pen, anantenna, and any other stick-like structure. The tip housing forsecuring a temperature sensor of the prior art comprises an essentiallyhard tip. Contrary to the prior art, the tip of this invention housingor securing the temperature sensor is essentially soft. FIG. 96D showsanother embodiment comprising a rod 2764 having a bulging sensor 2762surrounded by insulating material 2766, which extends beyond the end ofrod 2764.

The intelligent stylus of the invention can be used in the conventionalmanner with a metal cap, but contrary to the thermometers of prior art,the wire of the intelligent stylus of this invention exit said stylus inthe mid-portion of the stylus. As seen in FIG. 96-E, which shows PriorArt, wire 2782 of the thermometer 2784 of the prior art exit the rod2786 at the end 2788 of said rod 2786. Wire 2782 connect sensor 2790 toelectronic device 2792. The thermometers of the Prior Art that includesa rod and a wire comprises one end having the sensor and the oppositeend of the rod having the wire, such as found in Welch Allynthermometers, Filac thermometers, and the like.

FIG. 96-F shows another embodiment according to the invention, whereinsensor 2770 is housed in the end of the stylus 2768, wherein sensor 2770is covered with cap 2772 preferably made of metal, ceramic, or otherthermally conductive material and most preferably made of a metal, saidcap 2772 completely covering the end 2774 of the stylus 2768, and saidsensor 2770 is connected to a wire 2778 which exits stylus 2768 in themid-portion 2776 of said stylus 2768. The distance from the tip of themetal cap 2772 to the mid part 2776 of the stylus 2768, shown by arrow2769, measures preferably at least 30 mm and less than 300 mm, and mostpreferably at least 30 mm and less than 200 mm, and even most preferablyat least 20 mm and less than 40 mm. Wire 2778 which connects stylus 2768to an electronic device 2780 uniquely exits stylus 2768 at a mid-portion2776. Mid-portion or middle portion is referred in this invention as anyportion which is located between the two ends of the stylus or any rodlike structure.

FIG. 96-G1 shows another preferred embodiment, wherein a cap 2794housing reagent 2796 such as glucose oxidase is adapted on top of thesensing end 2798 housing sensor 2800 of the stylus 2802. Cap 2794 hasarms 2804 for securing cap 2794 on top of sensing end 2798. When bloodcontaining glucose is deposited on top of cap 2794, reagent 2796generates a reaction which is sensed by sensor 2800, such as anelectrochemical or optical sensor, generating a signal that istranslated into glucose level after standard processing. FIG. 96-G2shows in more detail specialized cap 2794 of FIG. 96-G1, which ispreferably essentially cylindrical, and houses reagent 2796. Cap furtherincludes arms 2804 and extension 2806 for handling and placementpurpose.

FIG. 96H shows a specialized end 2807 of the thermometer of thisinvention that includes a rod 2811 having a cap 2805 made of metal orthermally conductive material, said cap covering a temperature sensor2809. Dimension “2813”, represented by arrow 2813, said dimension goingfrom the edge of the cap 2805 to the tip of the cap 2805 corresponds tothe largest dimension of a metal cap of this invention. The preferredlength of dimension 2813 is equal to or less than 3 mm, and preferablyequal to or less than 2 mm, and more preferably equal to or less than1.5 mm, and even more preferably equal to or less than 1 mm.

FIG. 96J is another embodiment, wherein the stylus 2810 includes atouching end 2812 and a sensing end 2814, said sensing end 2814 having aslot 2808, said slot adapted to receive a strip 2818 such as a stripreagent for a chemical reaction including glucose oxidase detection ofglucose present in blood applied to said strip 2818. Stylus 2810 furtherincludes a detecting area 2816 which is adapted to receive strip 2818and detects the chemical reaction that occurred in said strip 2818, andproduces a signal corresponding to the amount of a chemical substance oranalyte present in strip 2818. Wire 2820 is connected in one to end todetecting area 2816 and exits stylus 2810 through the mid-portion 2822of said stylus 2810. The external wire portion 2826 connects the stylus2810 to a processing and display unit 2824. Touching end 2812 comprisesan end adapted to touch a screen, or alternatively an end adapted forwriting, such as a pen or pencil.

Although, a preferred embodiment includes a wired system, it isunderstood that the intelligent stylus of the invention also includes awireless system. In this embodiment, as shown in FIG. 96K, stylus 2830is connected by wireless wave 2828 with electronic wireless electronicdevice 2832. Stylus 2830 has three portions, sensing end 2836, touchingend 2844, and middle portion 2838. The sensor 2834 is housed on thesensing end 2836 of the stylus 2830 r and the mid portion 2838 of thestylus 2830 houses a printed circuit board 2840 which includes awireless transmitter, and power source 2842. Mid-portion 2838 preferablyhas a larger dimension than the sensing end 2836 housing the sensor 2834and larger than the touching end 2844. Dimension A-A1 of mid portion2838 is preferably larger than dimension B-B1 of the touching end 2844and larger than dimension C-C1 at the sensing end 2836.

The end opposite to sensing end 2836 preferably comprises touching end2844, with said touching end 2844 of the stylus 2830 being preferablyfree of any sensors and used to touch a surface 2846 of wirelesselectronic device 2832. This arrangement keeps surface 2846 of wirelesselectronic device 2832 from being scratched or damaged if the touchingend also would house a sensor. Likewise the arrangement prevents thesensor 2834 from being damaged by touching a surface, such as surface2846.

In reference to FIG. 96-L, another preferred embodiment of the inventionincludes a sensing-writing instrument 2850 comprising preferably arod-like shape article which comprises a sensing portion 2870 and awriting portion 2872. Sensing portion 2870 houses electronic parts 2864,2866, and battery 2868 and includes a sensing end 2852 which houses asensor 2854. Writing portion 2872 houses a writing element 2856 andincludes a writing end 2874. Writing element 2856 contains ink 2858 saidwriting element 2856 having a distal end 2860 adapted to deliver saidink 2858. The sensing-writing device 2850 further includes a wire 2862which connects sensor 2854 to electronics and display circuit 2864,which displays a value measured from sensor 2854, a printed circuitboard/microchip 2866, which calculates the value based on signal fromsensor 2854, and a power source 2868, all of which are preferably housedin the upper portion of the instrument 2850. It is understood thatwriting element 2856 can be mounted on a spring 2876. Sensing portion2870 is preferably of larger diameter than the writing portion 2872.Although the preferred embodiment includes the sensor 2854 being housedin the end opposite to the writing end 2874, it is understood that thesensor 2854 can be housed in the writing end 2874, preferably having arotating barrel and spring that includes the sensor 2854 and writingelement 2856 sitting adjacent to each other in the barrel (not shown).Upon actuation the sensor end is exposed, and with further actuation thesensor end retracts and the writing end is exposed. Writing element 2856can include a tube holding ink, and for the purposes of the descriptioninclude any article that can deliver a substance that allows writing,drawing, painting, and the like and includes pens of any type, pencilsof any type, wax-based writing instruments such as crayons, a paintbrush, and the like.

It is understood that any electronic device such as an electronic devicewhich recognizes alphabetical, numerical, drawing characters and thelike is within the scope of the invention. An exemplary electronicdevice includes a device with an electronic surface that recognizesstrokes by a writing instrument in which regular paper can be placed ontop of said electronic surface for the purpose of writing and convertingsaid writing into digital information by a variety of optical characterrecognition systems or similar systems, with said writing instrumenthousing a sensor in accordance with the present invention.

By way of illustration, but not of limitation, exemplary sensors andsystems for the intelligent stylus will now be described. The sensor cancomprise at least one of or a combination of temperature sensor,electrochemical sensor (such as a blood gas sensor for measuringoxygen), an enzymatic sensor (such as glucose oxidase sensor formeasuring glucose), a fluorescent sensor, and an infrared sensing systemincluding a light emitter and a photodetector adapted side-by-side, andusing preferably reflectance for measuring the level of a substance,such as glucose or oxygen saturation.

A plurality of sensing and detecting systems are contemplated includingan intelligent stylus comprising a microphone and a pressure sensor formeasurement of pulse and blood pressure. The end of the styluspreferably houses a piezoelectric sensor to detect sound, and amechanism to apply pressure, such a blood pressure cuff, in order tochange the blood flow and elicit a change in sound. The blood pressurecuff has a wireless pressure transmitter that transmits the pressureinformation to the electronic device, such as a PDA. When thepiezoelectric or microphone of the stylus detects a change in sound itsends a signal to the PDA, which then stores the pressure transmitted bythe pressure cuff, creating thus a coupling between the pressure beingmeasured by the cuff and the change in sound detected by the stylus. Itis understood that the stylus can include a pressure sensor coupled to amechanical pressure means that apply pressure in the blood vessel fordetection of the mean arterial pressure, and the change in pressurecorresponding to the arterial pressure. It is also understood that theend of the stylus of the invention can house a fiberoptic system orother optical system such as system for measuring fluorescent light, andfor illuminating the area being measured and identifying the arterialpulse.

Another preferred embodiment includes an antenna with sensingcapabilities, the sensing-antenna article comprises preferably arod-like antenna including a whip antenna and wire antenna which housesin its free end a sensor and the opposite end is void of any sensor andconnected to conventional radio electronics or communicationselectronics and ground plane such as antennas found in cellular phonesand radios. Although the sensor is preferably located at the end of theantenna, it is understood that the sensor can be housed adjacent to thefree end of the antenna. A preferred embodiment includes a cellularphone housing a temperature sensor at the free end of the antenna, withsaid cell phone comprising electronic means to convert the sensor signalinto a temperature signal, and further means to display by visual,audio, or other indicator the temperature measured. The radio or cellphone of the present invention is adapted to generate and process thesignal of a biological parameter being measured with the antenna, thusthe cell phone, radio, or other device with an antenna can then functionas a thermometer for measuring body temperature using a sensor housed inthe antenna. Besides measuring body temperature, the antenna can beadapted to measure temperature in general such as liquids and also formeasuring ambient temperature.

Accordingly, FIG. 96-M is another preferred embodiment showing atelephone 2880 including a dial pad 2888, a display 2890, electronics2892 and a sensing antenna 2882 having a sensor 2884 in its free end2886. Sensor 2884 is connected to ground plane and electronics 2894through wire 2895.

FIG. 96-N and FIG. 96-P show in detail exemplary arrangements of theantenna with sensing capabilities of this invention. FIG. 96-N showssensing antenna 2900 having two compartments, one compartment 2898housing sensor 2896 and wire 2902, and a second compartment comprised ofthe antenna 2904 for transmitting and receiving electromagnetic waves.Sensor 2896 can be positioned on the top part or the side part of thecompartment 2898. FIG. 96-P shows antenna 2910 having a sensor 2906 anda wire 2908 inside the antenna 2910. The method includes the step ofpositioning the free end of the antenna housing a sensor in appositionto the area being measured, such as the skin of the BT; generating anelectrical signal based on the value of the biological parameter beingmeasured, and reporting the value of the biological parameter such asdisplaying a numerical value. It is understood that any contact andnon-contact sensor or detector, can be housed in or on the antenna.

The system can further include a system for measuring wind effect. Inthis embodiment the temperature sensor is a thermistor. Upon actuationelectronics in the cell phone apply current to the thermistor in orderto increase the temperature of said thermistor. Since the antenna isexposed to air, the rate of increase of temperature of the thermistor isinversely proportional to the wind speed. With higher wind speed, thereis proportionally a need to increase in energy in order to maintain thetemperature of the sensor constant. Software can be adapted to identifywind speed, and thus heat or cold index, based on the ambienttemperature and the change in temperature of the thermistor being heatedup.

It is understood that the sensor at the end of the sensing-antenna or atthe end of the sensing-writing instruments can also include a probecover to avoid cross-contamination when touching a body part, or whentouching a drink to measure the temperature of such a drink. It is yetunderstood that software can be adapted to allow subtle changes intemperature corresponding to ovulation or pre-ovulation to be detected,with said cell phone or radio having means to identify such changes andindicators to display the information about ovulation.

It is understood that a variety of sensing and detecting arrangementsare contemplated as shown from FIG. 96-Q1 to FIG. 96-Q4. FIG. 96-Q1 is aplanar view of a rod-like sensing device such as a thermometer, astylus, a writing instrument, an antenna, and the like showing thesensing surface 2912 of a rod-like sensing device having a sensor 2914.Sensing surface 2912 can comprise entirely of a sensor or detector. Thepreferred largest dimension of sensing surface 2912 is equal to or lessthan 21 mm, and preferably equal to or less than 15 mm, and mostpreferably equal to or less than 10 mm. Considering sensor 2914 as asingle sensor, the preferred largest dimension of sensor 2914 is equalto or less than 15 mm, and preferably equal to or less than 10 mm, andmost preferably equal to or less than 5 mm. FIG. 96-Q2 is a side view ofanother preferred embodiment showing rod-like structure 2916 having aninfrared radiation detector 2918 and sensing surface 2920. FIG. 96Q-3shows a pair light emitter-light detector 2922 mounted in a rod-likestructure 2924, said sensor being disposed flush in relation to the endof said rod 2924. FIG. 96Q-4 shows a bulging light emitter-lightdetector pair 2926 of a rod-like sensing structure 2928.

FIG. 96R-1 is another preferred embodiment showing a spring-basedmeasuring portion 2930 including a hollow rod 2932 that works as atunnel, an adjustably positionable arm 2944, a spring 2936, and a sensor2934, said sensor 2934 being secured to a sensing support structure 2940and covered by a cap 2938. Spring 2936 is covered by an essentiallycylindrical-like structure 2952 which has free end 2946 and has a secondend 2942 attached to rod 2932 and/or arm 2944. Sensing support structure2940 includes preferably two portions, a distal portion 2948 housingsensor 2934, and a proximal part 2950 comprised of a rod-like portion,said portion being adapted to secure one end of the spring 2936. Thespring 2936 is connected to the proximal part 2950 of the supportstructure 2940 in one end and is connected to rod 2932 at the oppositeend. Any attachment means such as glue, heat, and the like can be usedto attach spring 2936 to support structure 2940 and rod 2932. Thepreferred length of the proximal part 2950, in which spring 2936 isattached to, is equal to or less than 7 mm, and preferably equal to orless than 3 mm, and most preferably equal or less than 2 mm. Thepreferred length of the rod 2932, in which spring 2936 is attached to,is equal to or less than 7 mm, and preferably equal to or less than 3mm, and most preferably equal to or less than 2 mm. Rod 2932 terminatesin adjustably positionable arm, 2944, which is preferably hollow and hasflexible characteristics and memory, and is similar to arm 2004 whichhas been previously described. The preferred length from the edge of theproximal part 2950 and the edge of the rod 2932, which corresponds tothe length in which spring 2936 is not in contact with any structure, isequal to or less than 9 mm, and preferably equal to or less than 4 mm,and most preferably equal to or less than 3 mm. The preferred diameterof spring 2936 is equal to or less than 10 mm, and preferably equal toor less than 4 mm, and most preferably equal to or less than 2 mm. Thepreferred diameter of rod 2932 is equal to or less than 10 mm, andpreferably equal to or less than 4 mm, and most preferably equal to orless than 2 mm. Sensor 2934 is connected to wire 2947 which is disposedinside the spring 2936, and inside rod 2932 and arm 2944. The preferredlength from the edge of cap 2938 to part 2932 is equal to or less than14 mm, and preferably equal to or less than 11 mm, and most preferablyequal to or less than 8 mm. The preferred largest dimension of sensor2934 is equal to or less than 14 mm, and preferably equal to or lessthan 10 mm, and most preferably equal to or less than 5 mm, and evenmore preferably equal to or less than 2 mm. The embodiment of FIG. 96R-1can be used with any support structure including those of theembodiments of FIG. 86A, FIG. 91, FIG. 92A, FIG. 92B and FIG. 92D aswell as FIGS. 100A to 100Z, said FIG. 92D showing by way of example theembodiment of FIG. 96R-1 integrated into eyewear.

FIG. 96R-2 is a planar view of the spring-based measuring portion 2930showing the surface of cap 2938 showing an exemplary sensor chip 2960disposed under said cap 2938, said cap 2938 preferably being made ofmetal or other heat conducting material. A soldering joint 2962 connectssensor chip 2960 to a wire 2964, and a second wire 2966 is connected tothe cap 2938 through solder joint 2968. The preferred diameter of cap2938 is equal to or less than 14.8 mm, and preferably equal to or lessthan 10.8 mm, and most preferably equal to or less than 5.8 mm, and evenmore preferably equal to or less than 2.8 mm.

FIG. 96S-1 to 96S-4 shows an exemplary embodiment for a measuringportion of this invention. FIG. 96S-1 shows measuring portion 2970comprised of a convex cap 2972 made preferably of copper, and includes asensor arrangement disposed under said cap 2972, said arrangementcomprised of sensor chip 2974 sandwiched between electrode 2976 andelectrode 2978 and connected to wire 2982, and includes a second wire2980 connected to cap 2972. FIG. 96S-2 shows measuring portion 2984comprised of a convex cap 2986, and includes a sensor arrangementdisposed under said cap 2986, said arrangement comprised of sensor chip2988 sandwiched between electrode 2990 and electrode 2992. Wire 2994 issoldered with electrode 2992 and wire 2996 is disposed between electrode2990 and cap 2986. FIG. 96S-3 shows the embodiment of FIG. 96S-1 inwhich convex cap 2972 is replaced by a flat cap 2998. This preferredembodiment provides the least amount of heat loss. FIG. 96S-4 shows theembodiment of FIG. 96S-1 in which flat copper cap 2998 is replaced by asolid metal cap 3000.

FIG. 96T-1 shows measuring portion 3002 including the sensor arrangementof the embodiment of FIG. 96S-3, in addition to spring 3004 seen in across sectional view, said spring 3004 being adjacent to wire portion3006, which is shown in its bent position (by small arrow) aftercompression of spring 3004, said wire portion 3006 being adapted forbending upon compression of spring 3004, and further including rod 3008which is attached to spring 3004 and houses wire portion 3010, said wireportion 3010 being unable to move or slide. FIG. 96T-2 shows detail ofthe wire portion 3006 forming a curve upon pressing of spring 3004. Thecurve formed by wire 3006 upon compression is limited by the diameter ofthe spring. It is understood that the method includes the step ofpositioning the sensor, compressing the spring, and generating anelectrical signal from said sensor. The dimension of the wire curve isadjusted to fit within the diameter of the spring.

FIG. 96U is a cross sectional diagrammatic view of a preferredembodiment of the measuring portion or sensing assembly 3012 of thisinvention, and includes a flat cap 3014. Preferred thickness of cap 3014from the edge of said cap 3014 to the tip of said cap 3014 is equal toor less than 2 mm, and the preferred diameter of said cap 3014 is equalto or less than 2 mm. Those dimensions are preferably used formeasurement of temperature or pulse. Cap 3014 is attached to sensor3016, said cap 3014 covering sensor 3016. Spring 3018 is connected inone end to cap 3014 and in the opposite end to rod 3020. A wire 3022connected to sensor 3016 is seen in a bent position and inside an areacomprised by the spring 3018. Spring 3018 is attached to cap 3014 in oneend and to rod 3020 at the other end. Wire 3022 is affixed to sensor3016 in one end and to rod 3020 in the other end in order to allow saidwire 3022 to bend and extend upon compression and decompression ofspring 3018. Measuring portion 3012 is covered by a structure 3024 madepreferably of a soft plastic and adapted to protect the spring 3018 andassociated components such as wire 3022, said structure 3024 preferablyshaped as a cylinder in which the distal end 3026 is open, allowing thusunobstructed movement of cap 3014 and sensor 3016. It is understood thatany material that works as a spring or which has compression anddecompression capabilities can be used in a similar manner as spring3018. Any foam, gels, or compressible material with spring capabilitiescan be used. It is also understood that any sensor or sensor system canbe used and replace cap 3014 including enzymatic sensors, opticalsensors, fluorescent light, a pair light emitter-light detector, aradiation detector including infrared radiation detector, and the like.It is also understood that preferred dimensions are chosen according tothe type of sensor being used.

FIG. 96V-1 is another embodiment showing another hand-held device formeasuring biological parameters, and illustratively shows theillustration of a hand held device 3030 including a body 3032 divided intwo parts, one straight part 3036 and a bent part 3034, said straightpart 3036 being of large diameter than bent part 3034, and said straightpart 3036 terminating in a wire 3042, and further including a sensingtip 3038, which secures sensor 3044 and includes an insulating material3040 surrounding sensor 3044. FIG. 96V-2 is a planar view of the handheld device 3030 showing sensing tip 3038 and sensor 3044 positioned onthe center of sensing tip 3038 and surrounded by insulating material3040.

FIG. 96V-3 is diagrammatic perspective view of a hand-held probe 3046including a sensing tip 3050, said tip 3050 being essentially convex,and a sensor 3048 disposed at the end of said probe 3046. Sensing tip3050 includes sensor 3048 and support structure 3052 which supports andinsulates said sensor 3048, said structure 3052 being preferablycomprised of soft insulating material. Sensor 3048 is connected to aprocessing and display unit 3054 through wire 3056 disposed preferablyinside probe 3046. FIG. 96V-4 is a diagrammatic perspective view of ahand-held probe 3058 having a pair light emitter-detector 3060 in thesensing tip 3062, said sensing tip 3062 having support structure 3064which preferably includes material that creates a barrier to infraredlight. The radiation emitter-detector 3060 is connected to a processingand display unit 3066 through wire 3068. FIG. 96V-5 is anotherembodiment showing a J-shape configuration of probe 3070 of hand heldmeasuring device 3080, said probe 3070 including two arms, 3074, 3072said two arms 3074, 3072 being of dissimilar length. Arm 3074 terminatesin sensing tip 3076, said tip 3076 securing sensor 3078. Arm 3074 islonger than the opposite arm 3072. Curve 3082 between two arms 3074 and3072 is adapted to be positioned over the nose, with arm 3074 beingpositioned in a manner so as to position sensor 3078 on or adjacent to abrain tunnel. Sensor 3078 is connected through wire 3084 to a printedcircuit board 3086 which houses processor 3088 and display 3090, saidprinted circuit board being connected to a power source 3092. Sensor3078 includes contact and non-contact sensors and detectors such as astand alone infrared radiation detector, said sensor being spaced fromthe site being measured or resting on the site being measured.

FIG. 97A to 97G shows exemplary manufacturing steps of a sensing devicein accordance with this invention. FIG. 97A shows an exemplary measuringportion 3102 and a sensor 3110 connected to a wire 3108. Measuringportion 3102 includes insulating material 3104 disposed in a manner tocreate a two level sensing tip 3106. The first manufacturing stepincludes creating a passage 3116 in material 3104 to accommodate sensor3110 and wire 3108. FIG. 97B shows material 3104 with passage 3116 andtwo holes 3112 and 3114 at the ends of passage 3116. Sensor 3110 andwire 3108 are inserted through material 3104. FIG. 97C shows an optionalnext step and includes bending the end 3109 of wire 3108 of the sensor3110. Passage 3116 is made preferably eccentrically to allow sensor 3110to be in the geometric center of sensing tip 3106 after being bent. Thisstep of bending the wire of a long rectangular sensor, such as thethermistor of this invention, allows passage 3116 through material 3104to be of small dimensions. Manufacturing may include a step of securingwire 3108 to material 3104 as shown in FIG. 97D, for example using apiece of glue 3120 or other attachment means. FIG. 97E shows plate 3118being disposed along the lower portion 3122 of measuring portion 3102.Plate 3118 is preferably made of a thin metallic sheet, said plate 3118having two ends 3124, 3126 and forming the arm and body of sensingdevice of this invention, said arm represented by portion 3134 of plate3118 and body represented by portion 3132 of plate 3118. One end 3124 ofplate 3118 is attached the lower portion 3122, sandwiching wire 3108between end 3124 of plate 3118 and measuring portion 3102. Next step, asshown in FIG. 97F, may include inserting a rubberized sleeve 3128including heat shrinking tube into plate 3118, but said step may alsooccur before attaching plate 3118 to measuring portion 3102, which ispreferably used if end 3126 of plate 3118 is of larger dimension thanend 3124. It is also shown in FIG. 97F the step comprised of attaching asoft plate 3130 to end 3126, said soft plate 3130 having preferably anadhesive surface 3136. FIG. 97G shows the finished sensing device 3100including rubberized sleeve 3128 covering portion 3134 corresponding tothe arm of sensing device 3100, soft plate 3130 being attached to end3126 of plate 3118 corresponding to the body of sensing device 3100, andmeasuring portion 3102 with sensor 3110. It should be noted that, as inaccordance to this invention, the sensor shown in FIGS. 97A to 97M-2 issupported and surrounded by the insulating material only and no othermaterial, said insulating material being essentially soft.

FIG. 97H shows a larger sensor 3138 with wire 3142 being insertedthrough passage 3140. In this embodiment manufacturing step does notinclude bending the wire. A larger passage 3140 is made for insertingthrough material 3142 a sensor 3138, including a bead thermistor, asensor covered by a cap, a thermopile, a radiation detector, and thelike.

FIG. 97J shows another preferred embodiment of a measuring portionaccording to this invention. FIG. 97J shows support structure 3144 of ameasuring portion 3148 comprised of a one level sensing tip 3146, saidsensing tip 3146 securing a sensor 3150. Wire 3152 is inserted throughhole 3154 into the support structure 3144 and disposed within supportstructure 3144 of measuring portion 3148. Wire 3152 is connected tosensor 3150 in one end and to a processing unit (not shown) at the otherend. FIG. 97K-1 is another embodiment showing wire 3156 disposed on theexternal surface 3157 of support structure 3158 of a measuring portion.In this embodiment there is no hole in the support structure 3158 andthe manufacturing step includes placing wire 3156 on the surface 3157 ofstructure 3158. As shown in FIG. 97K-2, manufacturing may include thestep of attaching or securing wire 3156 and/or sensor 3160 to structure3158 using glue or adhesive material represented by material 3162. FIG.97L is another embodiment showing a slit 3164 being cut through supportstructure 3166, and wire 3168 being disposed along slit 3164 and securedto said slit 3164. Manufacturing may further include the steps describedin FIGS. 97E and 97F.

FIG. 97M-1 is another embodiment showing a perforated plate 3170 havingin one end 3182 an opening 3172 for receiving a measuring portionrepresented herein by structure 3174 which is adapted to secure asensor. Perforated plate is divided in arm 3184 and body 3186, said bodyhaving a tunnel-like structure 3188. The step of a perforated platereceiving a measuring portion which holds a sensor may be followed byinserting a wire through the perforation in the plate. Accordingly, FIG.97M-2 shows measuring portion 3176 comprised of a structure 3174, wire3178 and sensor 3180, said measuring portion 3176 being attached toperforated plate 3170 at the end 3182. Sensor 3180 is connected by awire 3178 which goes through structure 3174 and run on the surface ofarm 3184 and then enters body 3186 through a hole 3190 and run insidetunnel 3188 of body 3186. Any of the measuring portions described inthis invention can be used in a hand held device and be disposed at theend of a probe.

This embodiment of the present invention includes apparatus and methodsfor measuring brain temperature and detecting analytes in blood vesselsdirectly from the brain by detecting infrared radiation from a braintunnel. As previously taught the brain tunnel allows directcommunication with the physiology and physics of the brain. Blood vesselof the brain tunnel remains open despite circulatory changes and/orvasoconstriction in other parts of the body and/or head.

The most representative and clinically significant representation of thethermal status of the body is brain temperature, and in particular thetemperature of the hypothalamic thermoregulatory center. This inventionidentified a central thermal storage area in the brain around thehypothalamic thermoregulatory center and disclosed the pathway of leastthermal resistance to the surface of the body, called Brain TemperatureTunnel because of its ability to work as a physiologic tunnel in whichthermal and biological events in one end of the tunnel can be reproducedin an undisturbed manner at the other end of the tunnel. The BTT is anundisturbed and direct thermal connection between this thermal storagearea in the brain and a specialized thermo-conductive peri-orbital skin.

This central thermal storage area is represented by the cavernous sinus(CS). CS is an endothelium-lined system of venous channels at the baseof the skull creating a cavity working as a pool of venous bloodadjacent to the hypothalamic thermoregulatory center. Venous blood inthe CS is slow moving which creates a homogenous distribution of thermalenergy. Venous blood is the blood type more representative of braintemperature. From a physical standpoint the slower moving blood willgenerate a lesser thermal gradient between the two ends of a vessel.Arterial blood, such as used in the prior art including temporal arterythermometer, is a fast moving blood which generates a significantthermal gradient and thus void the ability to reproduce accurately coretemperature or brain temperature.

This invention identifies unique thermal characteristics only found inthe CS. The CS collects and stores thermal energy from the various partsof the brain carried by slow moving deoxygenated blood that is inthermal equilibrium with the brain tissue, namely blood from thecerebral veins, meningeal veins, the sphenopalatine sinus, the superiorpetrosal sinus, the inferior petrosal sinus, and pterygoid venousplexus. By collecting blood from various parts of the brain, beinglocated in the vicinity of the hypothalamic thermoregulatory center, andhaving slow moving blood, which allows thermal equilibrium withsurrounding tissue and reduced heat loss, the CS functions as a centralthermal storage area. While uniquely thermally communicating withvarious parts of the brain and being located adjacent to thethermoregulatory center, this invention identifies that the CS thermallycommunicates in an undisturbed manner to the surface of the body througha path of minimal thermal resistance represented by the superiorophthalmic vein (SOV).

To examine the thermal path from brain to skin and create a function fordetermining the temperature of brain tissue, this invention examinedfrom a thermal standpoint each biological layer between the brain andthe skin at the brain tunnel and gave a thermal resistance value to eachstructure. The temperature gradient between the brain and the skin atthe brain tunnel is the summation of the individual temperaturegradients across each structure. The lower the thermal resistancebetween the brain and the measuring site, the less the temperaturedifference.

Since according to the second law of thermodynamics heat willautomatically flow from points of higher temperature to points of lowertemperature, heat flow will be positive when the temperature gradient isnegative. The metabolism taking place within the brain generates aconsiderable amount of heat, which the brain must dissipate in order tomaintain a consistent and safe operating temperature within the skull.This generates a positive heat flow. When the temperature of the skinarea of the brain tunnel and the temperature of the air around the skinof the brain tunnel is greater than the heat produced by the brain therewill be a reduction of the positive heat flow up to a point ofequilibrium between the brain and the skin area of the brain tunnel.

Most of the heat dissipation is accomplished by direct conductionthrough the circulatory system. However, the structure which enclosesthe brain providing physical protection also causes thermal isolation.As can be seen, these two requirements are in opposition to each other.Multiple layers of protection (1. thick skin, 2. subcutaneous tissue, 3.connective tissue aponeurosis (epicraninum), 4. loose areolar tissue, 5.pericranium, 6. cranial bone, 7 dura matter, and 8 cerebral spinalfluid) also represent multiple layers of thermal insulation. Thoseinsulating layers are represented by thermal resistance TR1,TR2,TR3,TR4,TR5, TR6, TR7 and TR8).

This invention identifies that with the exception of the thermal paththrough the BTT, heat energy flowing from within the brain to theexternal environment, including the forehead, must pass through about 8insulating structures, and there is a temperature drop associated witheach layer TR1 to TR8. As the heat flows in the direction of the coolerenvironment outside the body, we traced its path through multipleresistance layers which gives rise to a considerable temperature drop atthe surface of the skin in all areas of the body including the head. Theouter layer, especially, with a thick skin, fat tissue, and sweat glands(about 5 mm thick) contribute heavily to the thermal resistanceequation. The variability resulting from those layers will lead toinconsistent measurements which occur in any skin area in the whole bodyoutside the BTT, which were observed during testing and showed that skinareas outside the BTT area have 1.8 to 7.5 degrees centigrade differencebetween core temperature and skin temperature in skin areas outside theBTT.

Analysis of the pathway of least thermal resistance from the brain tothe surface of the body was performed and the functional and anatomicalarchitecture of the pathway characterized. A model for brain temperatureand the thermal resistance pathway was done. The model includes therelationship for heat transfer by conduction proposed by the Frenchscientist, J. J. Fourier, in 1822. It states that the rate of heat flowin a material is equal to the product of the following three quantities:

-   -   1. k, the thermal conductivity of the material.    -   2. A, the area of the section through which the heat flows by        conduction.    -   3. dT/dx, the temperature gradient at the section, i.e., the        rate of change of temperature T with respect to distance in the        direction of heat flow x.        The fundamentals of heat transfer for conduction show that the        greater the thermal conductivity, the less is the temperature        drop or loss for a given quantity of heat flow. Conversely, the        greater the thermal resistance in the heat flow path, the        greater the temperature drop. The flow of heat through a thermal        resistance is analogous to the flow of direct current through an        electrical resistance because both types of flow obey similar        equations.        The thermal circuit: q=ΔT/R  Equation 1-1    -   q=thermal energy flow,    -   ΔT=the temperature difference between two points,    -   R=the thermal resistance separating the two measuring points        The electrical circuit: i=ΔE/Re  Equation 1-2    -   i=the flow rate of electricity, i.e., the current    -   ΔE=voltage difference    -   Re=electrical resistance

The thermal resistance of the various insulating layers surrounding thebrain was represented with resistors to evaluate the relative degree ofresistance between different possible thermal paths from the brain tothe skin. Heat flux sensors were constructed to measure true surfacetemperature. This is a special temperature probe with two sensors. Athin insulator is placed between the two temperature sensors. One sensor(S1) contacts the surface whose temperature is to be measured (BTT), theother sensor (S2) is on the opposite side of the insulator (facing awayfrom the measurement site). If there is no net heat flow through theinsulation layer (Q=0 in equation 1-1), there can be no temperaturedifference (ΔT in Equation 1-1 must =0) between the two sensors. Thecontrol circuit of the heat flux temperature probe provides just enoughpower to a small heating element next to sensor S2 to equalize or bringto zero the difference in temperature between S1 and S2. By eliminatingthe heat flow to the external environment we minimize, if not totallycancel, the heat flow from the superior ophthalmic vein to the skinsurface under S1. This allows for a very accurate measurement of surfacetemperature (if Q=0 there is no temperature difference between the veinand skin). By comparing temperature measurements made with the heat fluxtemperature probe at the BTT site to those made with a miniaturetemperature probe (very low mass, 38 gauge connecting wires, and wellinsulated), it was possible to compute the temperature of the heatsource (represented by the CS) within the body.

One embodiment includes acquiring radiation emitted from a brain tunnel.Preferably, radiation is acquired using the region between the eye andthe eyebrow including scanning and/or positioning a radiation detectorover the brain tunnel. Preferably, the brain tunnel area is scanned forabout 5 to 10 seconds and the highest peak of infrared radiation fromthe brain tunnel is acquired, which reflects the peak temperature of thebrain tunnel area. Every time a higher temperature is detected a beep orsound is produced, thus when no more beeps are produced the user knowsthat the peak temperature was acquired. The temperature acquired isrepresentative of brain temperature reflected by blood from the brain.To acquire the core temperature of the brain, a specialized processingis used. The processing may take into account the thermal resistance(TR) of the path between the skin of the brain tunnel and the brain,which can be simplified by using the two main thermal resistances,namely TRB1 (representing thermal resistance due to skin) and TRB2,(representing thermal resistance due to the vascular wall and associatedstructures). Another factor in the calculation of core temperature mayinclude the thermal gradient between the two ends of the tunnel. Throughour experiments including using our fabricated heat flux sensors it wasdetermined that the thermal resistance by TRB1 and TRB2 accounts for upto 0.65 degrees Celsius. Hence in order to determine the coretemperature of the brain this invention includes apparatus and methodsadapted to perform processing for determining internal body temperature,represented by the core temperature of the brain, illustrated by theequation:T _(b) =T _(bt)+TR  (Equation 1-3)where T_(b) is the core temperature of the brain, T_(bt) is the peaktemperature of the skin of the brain tunnel as acquired by the radiationdetector, and TR is an empirically determined factor which includes thethermal resistance between the skin of the brain tunnel and the brain.

The processing includes a sum of thermal resistances between the sourceof thermal energy inside the body plus the temperature of the skin areabeing measured. Specifically, the core temperature of the brain includesthe temperature of the skin at the brain tunnel plus the sum of thethermal resistances of the structures between the skin of the braintunnel and the brain. More specifically, the preferred processingcircuit and processing includes the peak temperature of the skin area ofthe brain tunnel plus the sum of the thermal resistances between theskin of the brain tunnel and the brain, said thermal resistancecomprised of a factor equal to or less than 0.20 degrees Celsius andequal to or more than 0.05 degrees Celsius. Preferably, processingcircuit and processing includes the peak temperature of the skin area ofthe brain tunnel plus the sum of the thermal resistances between theskin of the brain tunnel and the brain, said thermal resistancecomprised of a factor equal to or less than 0.30 degrees Celsius andmore than 0.20 degrees Celsius. Most preferably, the processing circuitand processing includes the peak temperature of the skin area of thebrain tunnel plus the sum of the thermal resistances between the skin ofthe brain tunnel and the brain, said thermal resistance comprised of afactor equal to or less than 0.65 degrees Celsius and more than 0.30degrees Celsius. The radiation detector includes a processor andprocessing circuit having a computer readable medium having code for acomputer readable program embodied therein for performing thecalculations for determining core temperature, and may further include amemory operatively coupled with said processor, and a display, audio orvisual, for reporting a value. Another embodiment includes a furtherstep for determining the brain tissue temperature using the temperatureof the skin of brain tunnel that includes a factor pertaining to heatflow and environment temperature around the brain tunnel. To acquire thetemperature of the brain tissue (parenchymal temperature), a functiontaught by the present invention can be used and includes processing inthe device to compute the brain tissue temperature based on thermalresistance and the environment temperature around the brain tunnel. Theapparatus and methods includes a processing circuit that computes thebrain temperature as a function of the temperature of the skin at theend of the brain tunnel and a factor related to the temperature of airwithin a 90 cm radius from the entrance of the brain tunnel at the skin,described herein as BT-ET300 (brain tunnel Environmental Temperature at300 cm radius), also referred to herein as BT-300. The BT-300 factorvaries with the environment temperature around the area being measuredand is based on heat flow. It is understood that this function thatincludes a factor for each range of environment temperature can be usedin other parts of the body beside the brain tunnel.

The BT-300 varies according to the environment temperature around thebrain tunnel, or the skin target area being measured. If there isnegative heat flow, then the value of the BT-300 is equal to zero inEquation 1-4 below, and equal to 1 (one) in Equation 1-5. If there ispositive heat flow from brain to the environment of 0.1 degree Celsius,then BT-300 factor is equal to 1.003. Illustratively, if there ispositive heat flow from brain to the environment with a difference of0.2 degree Celsius, then BT-300 factor is equal to 1.006. If there ispositive heat flow from brain to the environment with a difference of0.3 degree Celsius, then BT-300 factor is equal to 1.009. If there ispositive heat flow from brain to the environment with a difference of0.5 degree Celsius, then BT-300 factor is equal to 1.012. If there ispositive heat flow from brain to the environment with a difference of0.5 degree Celsius, then BT-300 factor is equal to 1.015. If there ispositive heat flow from brain to the environment with a difference of0.6 degree Celsius, then BT-300 factor is equal to 1.018. If there ispositive heat flow from brain to the environment with a difference of0.7 degree Celsius, then BT-300 factor is equal to 1.021. If there ispositive heat flow from brain to the environment with a difference of0.8 degree Celsius, then BT-300 factor is equal to 1.024. If there ispositive heat flow from brain to the environment with a difference of0.9 degree Celsius, then BT-300 factor is equal to 1.027. If there ispositive heat flow from brain to the environment with a difference of1.0 degree Celsius, then the BT-300 factor is equal to 1.030. If thereis positive heat flow from brain to the environment with a difference ofequal to or more than 1.0 degree Celsius and less than 1.5 degreesCelsius, then the BT-300 factor is equal to 1.045. If there is positiveheat flow from brain to the environment with a difference of equal to ormore than 1.5 degrees Celsius and less than 2.0 degrees Celsius, thenthe BT-300 factor is equal to 1.060. If there is positive heat flow frombrain to the environment with a difference of equal to or more than 2.0degree Celsius, then the BT-300 factor is equal to 1.090. Therefore,equation 1-4 provides a method to calculate the corrected braintemperature.T _(bc) =T _(bt) *BT-300  (Equation 1-4)where T_(bc) is the core temperature of the brain corrected for heatflow from the brain, T_(bt) is the peak temperature of the skin of thebrain tunnel as acquired by the radiation detector, and BT-300 is afactor based on the heat flow.

Using equation 1-4, the corrected temperature of brain tissue can bedetermined with the following equation:T _(ct)=TR+(T _(bt) *BT-300)  (Equation 1-5)where T_(ct) is the corrected core temperature of the brain tissue,T_(bt) is again the peak temperature of the skin of the brain tunnel asacquired by the radiation detector, TR is an empirically determinedfactor which includes the thermal resistance between the skin of thebrain tunnel and the brain, and BT-300 is a factor based on the heatflow.

FIG. 98A is another embodiment of the apparatus and method of thisinvention showing a hand-held radiation detector 3200 held by the handof a subject 3202 and positioned in a preferred diagonal position inrelation to the plane of the face 3204. The preferred method includespositioning the end 3208 of an infrared detector 3200, or alternativelythe tip of an infrared detector, in any area below the eyebrow 3210,with the infrared sensor having a view of the brain tunnel area 3206.The preferred method includes positioning an infrared detector with anangle between 15 and 75 degrees in relation to the plane of the face,and preferably between 30 and 60 degrees, and most preferably between 40and 50 degrees, and even most preferably at a 45 degree angle withrespect to the x, y and z axes. The tip of the infrared detector ispositioned in a manner that the infrared sensor has an optimal view ofthe brain tunnel area. The infrared detector such as a thermopile ispointed at the roof of the orbit adjacent to and below the eyebrow.Preferably the sensor is pointed to the area of the tunnel next to thenose. Preferably the sensor is pointed to an area between the eye andthe eyebrow. It is understood that the plane of the face can include theplane of the forehead, surface of the face or the forehead, or similaranatomic structure. The reference point for determining angle of themethod can also include the floor or similar physical structure when thehead is held straight. Although the infrared detector can be positionedperpendicular to the face with the sensor viewing the brain tunnel areafrom this perpendicular position, the optimal position is diagonal andpreferably in a tri-dimensional manner the Z axis has an angle between15 and 75 degrees, and preferably between 30 and 60 degrees, and mostpreferably between 40 and 50 degrees, and even most preferably at a 45degree angle.

The method includes the steps of positioning an infrared detector in adiagonal position aiming at the brain tunnel from below the eyebrow,receiving infrared radiation from the brain tunnel, and generating anelectrical signal based on the received infrared radiation. The braintunnel may include an area between the eye and the eyebrow. Further stepmay include generating radiation or directing radiation by the detectorprior to the step of receiving radiation form the brain tunnel. Afurther step includes processing the signal and determining the bodytemperature or concentration of a chemical substance or analyte. Thebody temperature in accordance with this invention ranges preferablyfrom 15 degrees Celsius to 45 degrees Celsius.

Another embodiment of this invention includes a device for removablymounting sensors on spectacles and more particularly to a clip formounting a sensor on spectacles which includes a spring or a tensionring which provides the force to clamp the spectacles and an adjustablypositionable sensor anchored to the clip. The mounting sensing devicemay further include electronics such as a processor and reporting meanssuch as a LED and/or a wireless transmitter to report the value of abiological parameter. It is understood that a clamp for removablymounting sensors can be adapted for clamping any head mounted gear suchas spectacles, headbands, caps, helmets, hats, sleeping masks, and thelike.

The invention includes sensors, sensing systems, or detectors includinginfrared detectors adapted to removably clip onto spectacles in a mannerwhich permits the sensors to be positioned on or adjacent to a braintunnel. The sensor is more preferably adjustably positionable, and mostpreferably positioned at the roof of the orbit and between the eye andthe eyebrow. The present invention is designed to removably mountsensors or detectors of any type including optical sensors, pressuresensors, pulse sensors, fluorescent elements, and the like ontospectacles or head mounted gear. It is understood that the clip of thisinvention can be adapted to hold any therapeutic system including drugdelivery systems such as for example iontophoresis-based systems,thermal energy delivery devices such as for example thermo-voltaicsystems including Peltier systems and gels which change the temperatureof the area such as polypropyleneglycol. Any head mounted gear of thisinvention can hold or house a physical element, electrical device,substances, Peltier devices, resistors, cooling elements, heatingelements in a manner so as to position those cooling or heating elementson the brain tunnel area in order to change the temperature of the braintunnel, and consequently the temperature of the brain. Thus, thisembodiment can be useful for therapy of heatstroke and hypothermia.

In accordance with this invention, a clip is provided for mountingsensors on spectacles. Preferably a spring is used to retain the frontportion and back portion of the clip together and to provide thenecessary force to clamp the frame of spectacles or head mounted gear.Preferably the front portion houses power source and electronics whilethe back portion houses the sensor. The clip includes electronic housingmeans, support means, sensor attaching means movably mounted relative tothe support means, spectacle clamping means movably mounted relative tothe support means and clamping means such as a spring or tension ring.

FIG. 99A is a frontal diagrammatic view of a sensing clip 3212 of theinvention mounted on a spectacle illustrated by right lens 3244 and leftlens 3246. The sensing clip 3212 comprises support means 3214, sensingmeans 3216, right clamping system 3218 and left clamping systems 3222,and clamping means 3220 such as pressure applying means representedherein by a spring, which is preferably housed in the centrally locatedsupport means 3214. Right and left clamping systems 3218, 3222 eachcomprise a front and back clamping elements, which are essentiallysimilar and therefore only one side is illustrated. In this exemplaryembodiment the left side is the sensing side and therefore the leftclamping system 3222 is the side illustrated herein, said left clampingsystem 3222 is comprised of left front clamp element 3224 and left backclamp element 3226. Spring 3220 allows the force for right and leftclamping systems 3218, 3222 to clasp a spectacle or a portion of a headmounted gear. Sensing means 3216 includes sensor 3240 and can compriseany sensor or detector mentioned or described in the present invention.The sensing means 3216 preferably branches off from the top of thesupport structure 3214 or alternatively sensor 3240 is built-in in thetop part of the support structure 3214.

Support portion 3214 is centrally located and connects the rightclamping system 3218 and left clamp system 3222, said support portion3214 shown housing microprocessor 3236. Left front clamp element 3224preferably houses power source 3232 and left back clamp element 3226, inthe vicinity of the skin preferably houses a light source such as LED3234. It is understood however, that the LED 3234 can be housed in theleft front clamp element 3224, and in this embodiment, LED 3234 may becovering an element such as plastic, said plastic having a logo or otherindicia which is illuminated upon activation of LED 3234, which allowsviewing of the logo by an external observer. Wire 3242 connectselectronic circuit 3236 and power source 3232 to light source 3234 andsensor 3240.

Right and left clamping systems 3218, 3222 are preferably positioned oneither side of the nose of the wearer. Front clamping elements 3224 andback clamping element 3226 extend downwardly from a central supportportion 3214 and are adapted for clamping a structure such as lenses andframes of spectacles and head mounted gear. Front clamping element 3224and back clamping element 3226 may operate as legs which are alignedwith each other in order to clamp a structure such as spectacles or anyhead mounted gear. Spring means 3220 is preferably housed in centralsupport portion 3214 and serves to connect the right and left clampingsystems 3218, 3222 and to provide the necessary forces for clamping aspectacles frame and for maintaining a stable position for the sensingclip 3212.

FIG. 99B is a side view of embodiment of FIG. 99A showing sensing clip3212 mounted on top of left lens 3246. The sensing clip 3212 haspreferably a front portion and a back portion in each side, right andleft. The left front and back portion is similar to the right front andback portion, and therefore only the left side will be illustrated. Theleft side is illustrated herein as left back portion 3228 and left frontportion 3230, said front portion 3230 and back portion 3228 being joinedtogether by spring 3220. Back portion 3228 and front portion 3230includes in its end the back clamping element and front clamping elementrespectively, illustrated herein as left front clamp element 3224 andleft back clamp element 3226. The left back clamping element 3226 islocated adjacent to the eye 3248. Battery 3232 is preferably housed inthe left front portion clamp 3230, and more specifically in the frontclamp element 3224. LED 3234 is preferably housed in the back clampelement 3226. Wire 3242 connects the components of the front portion3230 to components of the back portion 3228 including sensor 3240. It isunderstood that battery, microchip, and light source can also be housedin the central support portion 3214 or in the back portion 3228.

The sensor 3240 is preferably disposed along the back portion 3228adjacent to the skin or on the skin. Sensor 3240 preferably has an arm3238 for adjustably positioning said sensor 3240. It is also understoodthat sensor 3240 may include any other structure adapted for adjustablypositioning a sensor or detector such as infrared detector on oradjacent to a target area for measuring a parameter. Any of the sensorsor detectors described in this invention can operate as sensor 3240.Wire 3242 connects electronics, light source and power source in thefront portion 3230 to a sensing system in the back portion 3228.

Arm 3238 may house a wire and may also have a light source disposed inits surface. It is understood that sensing means 3216 does not requirean arm to be operative. The sensing means of this invention can includea built-in sensor with no arm, said built-in sensor housed in supportportion 3214 or any of the clamping elements of this invention. Avariety of clip-on and clamping systems can have a sensor and be used tomeasure a parameter according to this invention including clip-onaffixed with lenses which when in an operative position a lens intersectthe visual axis and when in an inoperative position said lens is locatedaway from the visual axis of the wearer.

Upon actuation and pressing the clamps, the upper end of the frontportion 3230 and the upper end of the back portion 3228 are broughtclosed together, causing the front clamping element 3224 and backclamping element 3226 to move away from each other creating an openingfor receiving a structure such as spectacles. Upon release of the upperend front portion 3230 and the upper end of the back portion 3228 spring3220 causes front clamping element 3224 and back clamping element 3226to be brought together causing clamping of the spectacles or any headmounted gear by virtue of the clamping elements 3224 and 3226.

In another preferred embodiment, as shown in FIG. 99C, there is seen afrontal view of a sensing clip 3250, said sensing clip including twomain component parts, a clip 3252 and sensing means 3260 includingsensor 3261. The clip 3252 includes the central portion 3258, whichhouses a spring 3262, and right and left clamping systems 3264 and 3266.Right clamping system 3264 has a front clamp and a back clamp and leftclamping system 3266 has a front clamp and a back clamp, illustratedherein as left front clamp 3270 and a left back clamp 3256. The sensor3260 is secured to a back clamp element 3256 of clip 3252 by arm 3254.The left back clamping element and right back clamping element havepreferably a pad, illustrated herein as left pad 3268 for firmlyclamping eyeglasses between said back clamp 3256 and a front clamp 3270.

FIG. 99D is a side view of an embodiment of a sensing clip 3272 in aresting position showing front clamp 3274 and back clamp 3276. The backclamp leg 3276 preferably has a pad 3278 and houses sensor 3280.Although an arm attached to a sensor has been described, it isunderstood that a sensor can be secured or be part of a sensing clip ina variety of ways. Accordingly, in this embodiment of FIG. 99D thesensor 3280 is integrally molded in unitary construction with the backclamp 3276. In the resting position front clamp 3274 rests against backclamp 3276. Preferably front clamp element 3274 is longer than backclamp element 3276, said front clamp 3274 being located on the front ofa lens facing the environment and said back clamp 3276 located adjacentto the skin and/or the eye. FIG. 99E shows the sensing clip 3272 in anopen position with pad 3278 of back clamp 3276 located away from frontclamp 3274, for receiving a structure such as frame of eyeglasses or anyhead mounted gear.

It is contemplated that any other assembly for clamping, grasping, orattaching a sensing device to eyeglasses or head mounted gear can beused including clamping assembly without a spring. Accordingly, by wayof example, FIG. 99F shows the frontal view of a sensing device 3280that includes a central portion 3286 housing a right and left tensionbar 3282, 3284, right and left clamping systems 3294, 3296, right andleft pad 3288 and 3290 coupled to the tension bar 3282, 3284, and arm3292 connecting sensor 3294 to back clamp element 3298, said back clamp3298 having a LED 3300. FIG. 99G is a side view of sensing device 3280of FIG. 99F showing tension bar 3282 in a resting position, in whichleft pad 3290 rests against a left back clamp element 3300. FIG. 99H isa side view of sensing device 3280 showing tension bar 3282 in an openposition. In this embodiment the frame of the eyeglasses or anystructure can push the pad 3290 away from back clamp 3298 and place thetension bar 3282 in an open position for securing eyeglasses.

Any attachment means with a sensor for attaching to eyeglasses or headmounted gear is contemplated or any sensing device adapted to be securedto eyeglasses or head mounted gear. Accordingly, FIG. 99J shows sensingdevice 3302 adapted to be secured to the frame of eyeglasses by ahook-like structure 3304 which branches off from the main supportportion 3306 and includes sensor 3312. The main support portion 3306 hasa U configuration with two legs 3308, 3310 which houses electronics,light source, and power source (not shown).

FIG. 99K shows a sensing device 3320 mounted on spectacles 3322 havingright lens 3314 and left lens 3316. The sensing device 3320 includes ahook 3334 and is adapted to be supported by the frame of spectacles andincludes right leg 3324 and left leg 3326. The right leg 3324 houseselectronic processing circuit 3328 and left leg 3326 houses power source3330 and light source 3332. The right leg 3324 and left leg 3326 facethe environment and are disposed in front of the lens 3316. A sensor3336 on the opposite side of lens 3316 is facing the face of the user.

FIG. 99L shows sensing device 3340 clipped to eyeglasses 3338 saidsensing device 3340 including a dual sensing system, exemplarilyillustrated as right sensing system 3342 detecting pulse and leftsensing system 3344 detecting temperature. The structure of sensingdevice 3340 is similar to the structure described for sensing devices ofFIGS. 99A to 99K. Sensing device 3340 has a dual reporting system,illustrated herein as right LED 3346 and left LED 3348.

FIG. 99M is a side view of an exemplary embodiment of sensing device3350 having back portion 3354 and front portion 3356 and being securedto the frame of eyeglasses 3352, shown as ghost image. A sensor 3360 issecured to the back portion 3354 and a LED 3358 is positioned inalignment with the visual axis of user 3362.

In another preferred embodiment, as shown in FIG. 99N-1, there is seen aside view of a sensing device 3370, which has an opening 3364 and aninverted U shape configuration for receiving a frame of eyeglasses or ahead mounted gear. Sensing device 3370 has a front portion 3374 and aback portion 3376 and is preferably made of plastic or polymer that hasa memory or any shape memory alloy. Preferably internal surfaces 3382and 3384 have a gripping surface or are rubberized for securing astructure such as frame of eyeglasses. A sensor 3380 is attached to theback portion 3376 preferably by adjustably positionable arm 3366. Backportion 3376 house LED 3378, which is operatively connected to sensor3380. In this embodiment there is no spring, tension bar, clampingelement, and the like. A stable position is achieved by virtue of the Ushape configuration.

FIG. 99N-2 is a front view of the sensing clip device 3370 of FIG. 99N-1showing front portion 3374 having a printed circuit board 3378 andmemory area 3386, wireless transmitter 3388, and processor 3390. Abattery 3392 is housed in front portion 3374. Battery 3392 can bepermanently attached to sensing clip 3370 or be removably secured tosaid sensing clip 3370. Back portion 3376 houses LED 3394 and sensingmeans comprised of a sensor holder 3396 holding a sensor 3380, saidsensor holder 3396 being connected by arm 3366 to sensing clip 3370.FIG. 99N-3 is a frontal schematic view of the sensing clip 3370 of FIG.99N-1 mounted on eyeglasses 3398, shown as a ghost image.

FIG. 99P is a frontal view of dual sensing clip 3400, illustrativelyshown as a pair light emitter-light detector 3402, illustrated on theleft side, including radiation emitter 3404 and radiation detector 3406,for detecting glucose, and a second pair light emitter-light detector3408 located on the opposite side including radiation emitter 3410 andradiation detector 3412 for detecting oxygen and pulse oximetry.Besides, a temperature sensor or any other sensor can be used as asubstitute or in addition to the pair light emitter-detector. Sensingclip 3400 is adapted for performing measurements and detecting analytesby touching the area being measured or by being spaced away from thearea being measured. Wireless transmitter 3414 is adapted fortransmitting a wireless signal to a remotely placed device including atelephone 3416, watch 3418, shoe 3420, and a digital device 3422 such asa music player or computing device.

In addition, a sensing device can have arms which wrap around or thatare attached to the temples of eyeglasses or to a portion of a headmounted gear. The sensing means may branch off from the sensing device,which is adapted to position a sensor on or adjacent to a target area,such as a brain tunnel. It is also contemplated that any flip sunshadesor any type of clip-on sunshades can include sensors for measuring aparameter.

The present invention teaches a modular construction of head mountedgear for measuring biological parameters. Accordingly, FIG. 100A is aperspective diagrammatic view of another support structure comprised ofa specialized headband 3430 including a recess 3432 for receiving ahousing 3434, said housing being preferably a module removably attachedto said headband 3430 and includes right arm 3436 and left arm 3438.Arms 3436 and 3438 terminate in right and left sensing portion 3440,3442. Housing 3434 can comprise a box housing wires from sensors 3440,3442, and further include wire 3444 which exits box 3434 and is disposedalong the surface 3446 of headband 3430, and more particularly disposedon a groove 3448. Groove 3448 is adapted for being covered by a strip3450 attached to headband 3430. The strip 3450 is preferably made offabric and has a hinge mechanism, said strip 3450 being positioned overthe groove 3448 for securing wire 3444 to headband 3430. Edge 3456 ofstrip 3450 comprises preferably a hook and loop material which matches ahook and loop material 3454 secured to headband 3430. Wire 3444terminates in connector 3452, for connecting with a processor anddisplay unit (not shown).

FIG. 100B shows in more detail the BTT temperature module 3460 whichincludes a housing 3434 and a steel rod 3458 shaped as an inverted U andsecured to the housing 3434. Wire 3462 runs along or in the right rod3466, and connects sensor 3470 to PCB 3464 and processor 3478. Wire 3472runs along or in the left rod 3474 and connects sensor 3468 to PCB 3464and processor 3478. Processor 3478 selects the best signal, illustratedherein as selecting the highest of the two temperature signals beingmeasured at the right and left side, illustrated herein by sensors 3470and 3468. Processor 3478 can be operatively coupled to a memory 3476 andis connected with a display by wire 3482, said wire 3482 exiting housing3434 and terminating in an electrical connector 3484. Sensor portion3468 and 3470 can have any of the configurations described herein, andin particular the configuration and dimensions of measuring portion2006. Right rod 3466 and left rod 3474 can have any of theconfigurations described herein, and in particular the configuration anddimensions of arm 2004. The thickness of said arm 2004 can be convertedto a diameter of said arm 2004 since rods 3466, 3474 are essentiallycylindrical in nature and may function as arm 2004.

FIG. 100C is a frontal perspective view of another embodiment of asensing modular headband 3500 of this invention when worn by a user 3486and includes a headband 3480 having an area 3488 for receiving BTTtemperature module 3490, said area 3488 having an electrical connector3492 for electrically connecting module 3490 to headband 3480.Temperature module 3490 includes processor 3494, memory 3496, and arms3498 and 3502, said arms 3498 and 3502 terminating in measuring portion3504 and 3506 respectively. Measuring portions 3504 and 3506 aredisposed on or adjacent to the brain tunnel area 3508 and 3510, andlocated below the eyebrows 3512 and 3514. Electrical connector 3492 canfunction as an electrical pad and is connected to wire 3516 disposedalong the surface or within headband 3480.

FIG. 100D is a side view of another sensing modular headband 3520 ofthis invention when worn by a user (as ghost image) and including fourdifferent biologic parameter modules, namely a BTT temperature module3522, an ear temperature module 3524, an infrared detection module 3526illustrated herein as pulse oximetry module, and a behind the eartemperature module 3528. BTT temperature module 3522 is disposed on thesurface 3580 of sensing modular headband 3520 facing away from the skin3536 and includes adjustably positionable arm 3530 and measuring portion3532 positioned below and adjacent to the eyebrow 3534. Ear temperaturemodule 3524 may include a removably attached module secured by a clip3538 to the edge of headband 3520. Module 3524 may further include aretractable cord spool 3540 securing cord 3542 which terminates insensing probe 3544 which rests in the ear canal, said probe 3544including at least one of an infrared detector, a pair infraredemitter-infrared detector, a temperature sensor such as a thermistor,RTD, and thermocouple, and the like. Module 3524 also receiveselectrical input from behind the ear temperature module 3528, whichmeasures temperature behind the ear and more specifically at the lowerpart of the ear 3546 and/or around the ear lobe 3548. Behind the eartemperature module 3528 can be removably attached to headband 3520 byfastening structure 3556, such as a hook or loop, and includes a C-shapehousing 3550 and a sensor 3552, said sensor 3552 being connected tomodule 3524 by wire 3554 which is disposed on or along the C-shapehousing 3550 and terminates in said ear temperature module 3524.

Pulse oximetry module 3526 is located right above the eyebrow 3534 anddisposed in the internal face of headband 3520 adjacent to the skin 3536and includes a pair light emitter-light detector 3582 housed in anadhesive patch 3558 and further includes a wire 3560 which runs on theexternal surface 3562 of headband 3520 after going through hole 3564located in headband 3520. Wire 3566 of ear temperature module 3524, wire3568 of BTT module 3522, and wire 3560 of pulse oximetry module 3526,all run along the external surface 3562 and more specifically sandwichedbetween a movable lip 3570 which covers the wires 3566, 3568, 3560 andthe external surface 3562 of headband 3520. Wires 3566, 3568, 3560 exitheadband 3520 and connect to display and processing unit 3572 throughconnectors 3574, 3576, and 3578.

FIG. 100E is a frontal perspective view of another sensing modularheadband 3590 of this invention when worn by a user 3592 and includingtwo different biologic parameter modules, namely a BTT temperaturemodule 3594 and an ear monitoring module 3596, said modules 3594 and3596 including any sensor described in this invention and anytemperature sensors such as infrared radiation and thermistors. BTTtemperature module 3594 is disposed on the surface 3598 of sensingmodular headband 3590 and includes adjustably positionable arms 3600,3602 and measuring portion 3604, 3608 positioned below and adjacent tothe eyebrow 3606, 3610, and further including wire 3612 which exitsheadband 3590 and run behind the ear 3628 terminating in connector 3614which connects to wire 3616, said wire 3616 being connected to a displayand interface 3618. Ear monitoring module 3596 includes a wirelesstransmitter 3620 wirelessly connected to receiver and display 3622, andfurther including wire 3624 which terminates in ear probe 3626.

FIG. 100F is a diagrammatic view of another sensing modular headband3630 of this invention with eyes 3674, 3678 and nose 3680 seen below,said headband 3630 including eight different biologic parameter modules,namely a Brain Tunnel module 3632 illustrated by a radiation detector3634 on the left and a radiation emitter-detector pair 3636 on theright, an ear temperature module 3638, an infrared detection module 3640illustrated herein as pulse oximetry module, pulse detection module3642, a blood pressure detection module 3644, a brain monitoring modulesuch as a digitized EEG (electroencephalogram) module illustrated hereinby three electrodes 3648, 3650, 3652, a skin temperature module 3654,preferably using a sensor over the temporal artery, and a medical deviceholding module 3656, illustrated herein by a nasal canula module. Braintunnel module 3632 includes adjustably positionable arm 3660 terminatingin measuring portion 3636 illustrated herein by an infrared pairemitter-detector for analyte detection such as glucose and an adjustablypositionable arm 3662 terminating in measuring portion 3634 illustratedby an infrared detector positioned on or adjacent to the brain tunnelnext to the bridge of the nose and/or on the eyelid.

Pulse oximetry module 3640 is disposed on cavity or recess 3666 on theinternal face of headband 3630 and includes a pair light emitter-lightdetector 3664. Ear temperature module 3638 may include a cord 3646 thatterminates in sensing probe 3658 which rests in the ear canal 3668 andreceive radiation 3670 from said ear canal. Pulse detection module 3642and a blood pressure detection module 3644 can include any pressuresensing device, piezoelectric devices, and the like. Brain monitoringmodule allows directly monitoring of a patient's level of consciousnessto help determine and administer the precise amount of drug to meet theneeds of each individual patient and to avoid intraoperative awareness.Brain monitoring module works by using a sensor that is placed on thepatient's forehead to measure electrical activity in the brain from theEEG and the activity is digitized and displayed as a numerical value.Brain monitoring module allows customized amount of anesthetic andsedative medication to be delivered to the patient and therefore ensurethat they are unconscious and free of pain, yet able to wake-up quicklyand experience minimal side-effects from anesthesia and sedation. Brainmonitoring module 3646 is illustrated herein by three electrodes 3648,3650, and 3652. The information from the electrodes 3648, 3650, 3652 isprocessed and a number achieved which provides a direct measure of thepatient's level of consciousness allowing clinicians to determine themost effective anesthetic and sedative mix, consequently patients havefaster, more predictable wake-ups and higher-quality recoveries withless nausea and vomiting. The brain monitoring module may include anexternal monitor that analyzes and displays EEG signals, and thenconverts EEG signals to digital data, and then transfers the data to theexternal monitor for processing, analysis, and display. Nasal canulamodule includes a canula that goes up over the nose, and preferably notto the sides as per prior art. Modular nasal canula 3672 is secured byfastening means such as hooks and/or VELCRO and disposed on the surfaceof the headband 3630. The apparatus and method for supporting the nasalcanula includes a plurality of hooks in the head mounted gear such as aheadband of FIG. 100F or the frame of FIG. 100X, suspending thus thecanula and supporting the canula along the surface of the head mountedgear, prevented from shifting during sleep and transport.

FIG. 100G is a diagrammatic cross sectional view of a sensing modularheadband 3680 of this invention showing the disposition of the modulesin the internal surface 3682 facing the skin 3684 and the externalsurface 3686 of headband 3680 facing away from the skin 3684. Strap 3688is adapted to be secured to skin 3684 as pointed by large arrows, saidstrap 3688 having an area and/or recess 3690 on the external surface3686 for receiving a brain tunnel module 3692, said area or recess 3690preferably made of a thin sheet of plastic or other polymer adapted togive stability to the module; and two areas or recesses 3694, 3696 onthe internal surface 3682 for receiving an infrared module 3698 and askin temperature module 3700. The Brain Tunnel includes two areas 3702,3704 indicating the junction of right and left adjustable arms (notshown in cross sectional view) to the housing 3730, with wires 3706,3708 connecting wires from adjustable arms to a processor 3712. Wire3710 connects processor 3712 with a display unit (not shown), said wire3710 being disposed between the external surface 3686 and a lip 3714,made preferably of fabric or any pliable material. Area 3690 haspreferably two plugs 3716, 3718 for fastening and securing a module suchas a snap-on action to secure the module to the recess or cavity. Plugs3716, 3718 can also work as electrical connectors.

Pulse oximetry module 3698 is disposed on cavity or recess 3696 on theinternal face 3682 of strap 3688 and includes a pair light emitter-lightdetector 3720. Wire 3722 connects pair 3720 with a display unit (notshown), said wire 3722 being disposed between the external surface 3686and a lip 3714 after said wire 3722 goes through a hole 3724. Skintemperature sensor module 3700 is disposed on cavity or recess 3694 onthe internal face 3682 of strap 3688 and includes a sensor 3726. Wire3728 connects sensor 3726 with a display and processing unit (notshown), said wire 3728 being disposed along the internal surface 3682facing the skin 3684. There is also shown the flap 3714, also referredas lip, being connected to external surface 3686 by a hook and loopfastener Wire 3710 connects processor 3712 with a display unit (notshown), said wire 3710 being disposed between the external surface 3686and a lip 3714, made preferably of fabric or any pliable material.

FIG. 100H is a diagrammatic planar view of the sensing modular headband3680 showing the external surface 3686 of strap 3688, said externalsurface 3686 having area or recess 3690 for receiving a brain tunnelmodule 3692. Area 3690 has preferably two snap-on plugs 3716, 3718 forfastening and securing a module. There is also seen the hole 3724 andthe impression of plastic sheet of area 3696 on the external surface3686, which secures an infrared detection module. There is also shownthe flap 3714, also referred as lip, being connected to external surface3686 by a hook and loop fastener 3732.

FIG. 100J is a diagrammatic cross sectional view of a sensing modularheadband 3740 of this invention showing the disposition of the moduleson external surface 3742 of headband 3740 facing away from the skin3744. Strap 3746 is adapted to be secured to skin 3744 as pointed bylarge arrow, said strap 3746 having an area and/or recess 3750 on theexternal surface 3742 for receiving a brain tunnel module 3744, saidarea, cavity, or recess 3750 preferably made of a thin sheet of plasticor other polymer adapted to give stability to the module; and anotherspecialized area or recesses 3752 for receiving an infrared module 3754.Wire 3756 connects brain tunnel module 3744 with a display andprocessing unit (not shown), said wire 3756 being disposed between theexternal surface 3742 and a flap 3758. Area 3750 has preferably twoplugs 3760, 3762 for fastening and securing a module.

Pulse oximetry module 3754 is disposed on the cavity or recess 3752 onthe external surface 3742, said pulse oximetry module 3754 including apair light emitter-light detector 3756. Area, recess, or cavity 3752 ofstrap 3746 has preferably two openings 3758, 3748 for respectivelyreceiving light emitter 3770 and light detector 3772. Light emitter 3770and light detector 3772 are preferably disposed in a manner to presssuch emitter 3770 and detector 3772 against skin 3744 and create anindentation. Openings 3758 allow light to be directed at the skin 3744by emitter 3770 and light to be received by detector 3772 throughopening 3748. Plugs 3764 and 3766 are disposed on the bottom of recess3752 for fastening and firmly securing the module 3754 to strap 3746.Wire 3768 connects pulse oximetry module 3754 with a display andprocessing unit (not shown), said wire 3768 being disposed between theexternal surface 3742 and a flap 3758. Internal surface 3778 of strap3746 may include a peel-back adhesive 3776, which exposes an adhesivesurface for more stable securing strap 3746 to a body part. The oxymetrymodule is preferably located in the headband portion that is above theeye, said oximetry module being next to the module for temperaturemeasurement.

All the modules described herein preferably physically conform to a bodyportion of a patient, such as a forehead, and provide a firm pressingengagement between the sensors and the living creature's body portion.The pair light emitter-detector may include a flexible structure such asa flexible patch, which is physically conformable and attachable to thesubject's body portion. The pair light emitter-detector includes a lightsource assembly for illuminating the patient's body portion, and a lightdetector assembly for measuring reflected light. When the pair lightemitter-detector is conformably applied to the recess or cavity of thesensing headband, preferably using the snap-on plugs of said headband,localized pressure is exerted on the body portion at the points ofcontact with the light source and light detector assemblies, and/or theelectrodes, and/or the temperature sensors and/or the pressure sensorsand pulse sensors, and any of the sensors of this invention.

As in conventional pulse oximetry sensors, the light emitter or lightsource may include two light-emitting diodes emitting light at red andinfrared wavelengths, and the light detector assembly may include acorresponding two or more photodetectors. It is understood that a singlelight detector can be used to detect light at both wavelengths. Theelectric signals are carried to and from the light source and lightdetector assemblies by an electric cable which terminates at anelectrical connector, said connector being connected to control andprocessing circuitry and display.

The present invention teaches a method and apparatus for reusingexpensive parts while making the least expensive part, the onlydisposable part. Electronics and medical sensors are expensive and dueto the arrangement of the invention, those expensive parts do not remainin contact with the skin and do not have adhesive surfaces adhering tothe skin. The modular construction in which an optical sensor is theonly portion touching the skin surface, allows easy cleaning of saidoptical sensor and reutilization, such as for pulse oximetry. Fortemperature measurement a very low cost disposable cover is the onlydisposable material, which is required for covering the sensor thatrests on the BTT. Since in the arrangement of the invention, preferably,the electronics, sensors, and other expensive parts do not touch theskin, said parts can be reused. Since the arrangement is done in amanner in which only the forehead material touches the body, and theforehead material is the least expensive of the material sitting on theforehead, and actually really low cost. The device of the inventionincludes reusable parts and disposable parts.

FIG. 100K is a diagrammatic planar view of the external surface of thesensing modular headband 3740 showing the external surface 3742 of strap3746, said external surface 3742 having area or recess 3750 forreceiving a brain tunnel module 3744; and area or recess 3752 forreceiving a pulse oximetry module 3754. Area 3750 has preferably twosnap-on plugs 3760, 3762 for fastening and securing a module. Area 3752has preferably two snap-on plugs 3764, 3766 for fastening and securingan infrared module, and openings 3758, 3748 for allowing passage oflight to/from the skin to light emitter-detector pair 3756. There isalso shown the flap 3758, also to referred as a lip, being connected toexternal surface 3742 by a hook and loop fastener 3774.

FIG. 100L is a diagrammatic planar view of the internal surface 3778 ofthe sensing modular headband 3740 showing the adhesive surface 3780exposed after removing the backing 3776. Method includes using strapsthat have adhesive surface in different locations, allowing thus theskin to breathe more properly. Accordingly, a first strap has adhesivesurface in the center, said strap is used for 3 days for example. Afterthe 3 days, a new strap is applied, namely a second strap which hasadhesive only on the side parts but not the central part as with thefirst strap, thus allowing area covered by adhesive to breathe since thearea will not be covered consecutively with adhesives.

FIG. 100M is a diagrammatic planar view of an exemplary cavity or recess3782 for receiving a module 3784 for monitoring biological parameters.Cavity 3782 may include an adjacent housing for housing electroniccircuit and printed circuit board 3786 in addition to a processor 3788,wireless transmitter 3790, and display 3792.

FIG. 100N is a diagrammatic side view of another embodiment comprised ofa head mounted gear 3800, illustrated herein by a cap worn by a user,and including arm 3796 terminating in measuring portion 3794, said arm3796 being secured to the cap 3800 and further including a wire 3798disposed along the cap 3800 and connected to a processing and reportingunit 3802. The reporting unit 3802 may audibly report the value of aparameter being measured, and further include an ear bud assembly 3804connected by wire 3806 to processing and reporting unit 3802.

FIG. 100P is a diagrammatic perspective view of another embodimentcomprised of a head mounted gear 3804, illustrated herein by a cap wornby a user 3822, and including arm 3806 terminating in measuring portion3808, said arm 3806 being secured to the cap 3804, and further includinga wire 3810 disposed along the cap 3804 and connected to a secondmeasuring portion 3812, said measuring portion 3812 having a housing3816 and a sensor 3814. The measuring portion 3812 is disposed under thebrim of the cap 3804, with said measuring portion 3812 having a housing3816 which is secured to the cap 3804. Sensor 3814 is pressed againstthe skin by housing 3816, said sensor comprising any of the sensors, orpair light emitter-detector, or infrared detector of this invention.Wire 3818 connects measuring portions 3808 and 3812 to processing,transmitting, and reporting unit 3820 disposed in the back of the user3822.

FIG. 100Q is a diagrammatic perspective view of another embodimentcomprised of a head mounted gear 3824, illustrated herein by a cap, andincluding measuring portion 3828 and 3826 housing respectively aninfrared detecting system 3830 and piezoelectric system 3832 beingsecured to the cap 3824, and further including a groove 3826. Measuringportions 3828 and 3826 are movable and may slide on a groove shown byarrow, and illustrated herein as groove 3840 for proper positioning ofsensor 3830. Wire 3834 and wire 3836 join at the back of the cap 3824and form a single wire 3838 that connects to a processing and reportingunit (not shown). It is understood that the measuring portions can beconstructed as removably attached modules as previously described forheadbands.

FIG. 100R is a diagrammatic perspective view of another embodimentcomprised of a head mounted gear 3842, illustrated herein by a buretteworn by a user 3844, and including arm 3846 terminating in measuringportion 3848, which is disposed on or adjacent to a physiologic tunnel3850 between the eye 3866 and the eyebrow 3868 next to the nose 3852,said arm 3846 being secured to the burette 3842, and further including awire portion 3854 disposed along the burette 3842 and connected to aprocessing and transmitting unit 3856. A second arm 3858 terminates in asecond measuring portion 3860, which is disposed on or adjacent to asecond physiologic tunnel 3862 between the eye 3866 and the eyebrow 3868next to the ear 3864, said arm 3858 being secured to the burette 3842,and further including a wire portion 3870 disposed along the burette3842 and connected to a processing and transmitting unit 3856. A thirdarm 3872 terminates in a third measuring portion 3874, which is disposedon or adjacent to a third physiologic tunnel 3876 behind the ear 3864,said arm 3872 being secured to the burette 3842, and further including awire portion 3878 disposed along the burette 3842 and connected to aprocessing and transmitting unit 3856. It is understood that any of thearms of this invention may be adjustably positionable and extendableaccording to the application.

FIG. 100S is a diagrammatic perspective view of another embodimentcomprised of a head mounted gear 3880, illustrated herein by a lightsource worn by a user 3882, and including arm 3884 terminating inmeasuring portion 3886, which is disposed on or adjacent to aphysiologic tunnel 3888 adjacent to the eyebrow 3890, said arm 3884being secured to the sensing head light 3880, and further including awire portion 3892 disposed on or within the head light 3880 andconnected to a processing and transmitting unit 3894. Head light 3880has an arm 3896 for securing said head light 3880 to the head 3898 ofthe user 3882, said arm 3896 having a housing that includes an oxygen oranalyte measuring device 3900, illustrated herein by a pair radiationemitter-radiation detector 3902, which is connected by wire 3904 to aprocessing and transmitting unit 3894.

FIG. 100T is a diagrammatic perspective view of another embodimentcomprised of a head mounted gear 3910, illustrated herein by a sensingvisor worn by a user 3912, and including arm 3914 terminating inmeasuring portion 3916, and terminating in a second measuring portion3918 measuring a second parameter, said arm 3914 being secured to thesensing visor 3910 by fastening means 3920 such as a loop anchored tosaid sensing visor 3910. Sensing visor 3910 may include a microphone3928 disposed along the side of the face and connected to a processing,transmitting, and reporting circuit 3922 via stalk 3930, and may furtherinclude a display 3924 for visual display of data or informationconnected to a processing, transmitting, and reporting circuit 3922 viawire 3932. Sensing visor 3910 may include an ear bud assembly 3926connected to a processing, transmitting, and reporting circuit 3922 viawire 3934. This embodiment includes athletic applications in which anathlete wants to report to a coach a value of biological value or otherinformation. Accordingly, the user receives the information audibly bythe ear bud assembly 3926 or visually by display 3924, and thencommunicates the relevant information via microphone 3928.

FIG. 100U is a diagrammatic perspective view of another embodimentcomprised of apparel or clothing 3940, illustrated herein by asensing-enabled shirt worn by a user 3942, and including a moldable wire3944 preferably with memory for more stability and being supported bythe ear or other fasteners (not shown). Wire 3944 terminates in anadjustably positionable arm 3946, which further terminates in measuringportion 3948. Arm 3946 further includes a measuring portion having asensing system 3958 contained in an adhesive patch 3956 and applied tothe forehead of user 3942. Wire 3944 terminates in a support structure3950 secured to the collar 3952 of sensing shirt 3940, said supportstructure 3950 being electrically connected via wire 3960 to a reportingand display unit 3954 preferably secured to a piece of clothing.

FIG. 100V is a diagrammatic perspective view of another embodimentcomprised of head mounted gear 3962, illustrated herein by a helmet, andincluding arm 3964 terminating in measuring portion 3966 comprised of atemperature sensor, said arm 3964 being disposed on or within helmet3962 and being connected to a processing, transmitting, and reportingcircuit 3968 via wire 3970. Sensing-enabled helmet 3962 may include anear bud assembly 3972 connected to a processing, transmitting, andreporting circuit 3968 via wire 3976. Sensing-enabled helmet 3962 mayalso include a second sensor 3974 for measuring pulse and disposed alongthe side of the head, said sensor 3974 being connected to a processing,transmitting, and reporting unit 3974 via wire 3978. Unit 3974 mayfurther include a music player, which adjusts to a lower volume in casethe value of biological parameter is audibly transmitted.

FIG. 100X is a diagrammatic view of another sensing frame 3980 of thisinvention, said frame 3980 including seven different biologic parametermodules, namely a Brain Tunnel module 3982 illustrated by a radiationemitter-detector 3984 on the left and a radiation emitter-detector pair3986 on the right; an ear monitoring module 3988, an infrared detectionmodule 3990 illustrated herein as pulse oximetry module, pulse detectionmodule 3992, a behind the ear detection module 3994, a skin temperaturemodule 3996, preferably using a sensor over the temporal artery, and amedical device holding module 3998, illustrated herein by a nasal canulamodule. It is understood that although removably attached modules aredescribed, the invention includes modules being permanently attached andthe frame working as an integral one piece construction, oralternatively some devices are removably attached and some arepermanently affixed to the head mounted gear or eyeglasses, and thoseconfigurations apply to all devices described in this application.

Brain tunnel module 3982 includes adjustably positionable arm 3400terminating in measuring portion 3984 illustrated herein by an infraredpair emitter-detector for analyte detection such as glucose and anadjustably positionable arm 3402 terminating in measuring portion 3986illustrated by an infrared emitter-detector positioned on or adjacent tothe brain tunnel next to the bridge of the nose and/or on the eyelid anddetecting pulse and oxygen. The housing 3414 of the pulse oximetrymodule 3990 branches off from the frame 3980 and it is seen located onthe right side of frame 3980 with the pair emitter-detector locatedabove the eyebrow 3404. Ear monitoring module 3988 may include a cord3406, with or without a retractable cable, from the frame 3980, saidcord 3406 terminating in sensing probe 3408 which rests in the ear canaland receive radiation from said ear canal. Pulse detection module 3992branches off the frame 3980 and is adapted to detect pulsation of ablood vessel using a sensor 3416 disposed in said module 3992, saidsensor 3416 being located above the eyebrow 3410 and including anypressure sensing device, piezoelectric devices, tonometric device, andthe like. Skin temperature module 3996 branches off the frame 3980includes a temperature sensor 3412 preferably positioned over thetemporal artery or in the vicinity of the temporal artery. Behind theear monitoring module 3994 includes a sensor 3420 located in frame 3980,and more specifically at the end of the temples 3418, and even morespecifically at the free end 3422 of the temples 3418. Nasal canulamodule 3998 includes a canula 3999 that goes up over the nose, andpreferably not to the sides as per prior art. Modular nasal canula 3998is secured by fastening means such as hooks and/or loops disposed alongthe frame 3980 and illustrated herein by hook-loop 3424, 3426, 3428, onthe left side and one hook 3430 illustrated on the right side of frame3980. By way of illustration nasal canula is shown on the left side asbroken down lines along the frame 3980, but it is understood that saidnasal canula is disposed in the same manner on the right side. Anyfastening means to secure a nasal canula to the frame of eyeglasses canbe used.

Wire 3432 connects infrared module 3390 to a processing and displaycircuit 3434 through electrical connector 3436. Wire 3438 connects earmonitoring module 3988 to the processing and display circuit 3434through electrical connector 3436. Wire 3440 connects behind the earmonitoring module 3994 to the processing and display circuit 3434through electrical connector 3436. Brain Tunnel module 3982, pulsedetection module 3992, and skin temperature module 3996 connect to aprocessing and display circuit 3442 through wire 3446 and electricalconnector 3444.

FIG. 100Y is a diagrammatic side view of another embodiment showingsensing frame 3450 worn by a user 3448, and including: a behind the earmonitoring portion 3452 comprised of a chemical sensor 3456 andtemperature sensor 3458, said monitoring portion 3452 being integralwith frame 3450; a skin temperature portion 3454 comprised of atemperature sensor 3460 being integral with frame 3450; an infraredemitter-detector 3462 located along the lens rim 3464; and a radiationdetector 3466 held by an adjustably positionable arm 3468 for detectingradiation naturally emitted from the brain tunnel. Chemical sensor 3456can include sensors for analyzing sweat such as glucose sensors,electrolyte sensors, protein sensors, and any analyte present in sweator on the surface of the body.

FIG. 100Z is a diagrammatic planar view of another embodiment showingspecialized sensing frame 3470 comprised of an essentially round framefor adjusting said frame 3470 to the head of a user and having temples3472, 3474 which are adapted for securing the frame 3470 to head of theuser by pressure means. Contrary to prior art the sensing frame of thisinvention does not have hinges. There is also seen a dual temperaturesensor 3476, 3478 held by arms 3480, 3482, nose pad 3484 for nosesupport, and processing circuit 3488. Wire 3486 connecting sensors 3476,3478 are disposed on or within frame 3470. Processing circuit 3488 isadapted to select the highest temperature from sensors 3476 and 3478 andreport said highest value, or alternatively processing circuit 3488 isadapted to select the most stable signal from sensors 3476 and 3478, andreport said value.

Another embodiment includes methods and apparatus for determining andpreventing intraoperative awareness and detecting brain activity basedon body temperature, more specifically temperature from the BTT.

The method and apparatus includes automated feed back control of aninfusion pump based on the BTT temperature for automated and preciseadjustment of infusion rate of drugs, such as anesthetics or sedatives,based on body temperature, and more particular core-brain temperature.

A first step determines the body temperature, and a second stepdetermines if the temperature is increased. If yes then increaseinfusion rate by the pump. With an increased core temperature duringanesthesia there will be increased drug metabolism, in which drugs areconsumed faster, thus requiring increased infusion rate. With adecreased core temperature during anesthesia there will be reduced drugmetabolism, in which drugs are consumed slower, thus requiring decreasedinfusion rate.

In the Intensive Care Unit, the apparatus and methods adjust rate ofinfusion of drugs, such as vasoactive drugs, based on the bodytemperature. With decreased core temperature patient requires warming,which may lead to vasodilation if done in excess leading to hypotension,which then requires administration of costly and dangerous drugs such asvasoconstrictors as epinephrine. Thus, with the present invention bycarefully and precisely titrating the warming or cooling of the bodybased on the core temperature all of those issues can be avoided.

In addition, this invention provides a method and apparatus to determinebrain awareness and detect risk of intraoperative awareness. If there isincreased temperature during surgery, leading to increased drugmetabolism, leading to a more superficial level of anesthesia and riskof intraoperative awareness, thus the method and apparatus of theinvention adjusts the rate of infusion and increase the rate ofinfusion. With increased brain temperature there is an increase in bloodflow to the brain, which increases the risk of intraoperative awareness,thus the method and apparatus of the invention adjusts the rate ofinfusion and increase the rate of infusion. If there is decreasedtemperature during surgery, leads to decreased drug metabolism, leadingto more anesthetic drugs being available, which places the patient at adeeper level of anesthesia, and which can cause complications and deathbesides increased hospital stay and time for recovery. Thus, with thepresent invention, the level of anesthetic is precisely titrated and ifthere is lower core temperature, there is a consequent adjustment of theinfusion rate with reduction of the infusion rate. With decreasedtemperature there is also reduced blood flow to the brain, whichdecreases the risk of intraoperative awareness, thus the method andapparatus of the invention adjusts the rate of infusion and decreasesthe rate of infusion. Integration of any pump drug with BTT signal canbenefit adjustment of infusion rate of some of the most common surgicalprocedures including cardiac and cardiothoracic, trauma, neurosurgical,long surgeries, and high risk surgeries and surgeries in whichvasodilators cannot be used, or patients with predisposition to shock orhypotension.

There are many clinical benefits due to integration of a BTT signal witha pump, including:

-   -   1) Automated and more precise adjustment of flow rate    -   2) To achieve better depth of anesthesia    -   3) To reduce risk of intraoperative awareness (increased brain        temperature associated with risk of intraoperative awareness)    -   4) Eliminate/reduce the potential for both under- and overdosing    -   5) Maintenance of drug levels within a desired range    -   6) Optimal administration of drugs    -   7) Reduced drug use    -   8) Reduced surgical time    -   9) Reduced assisted ventilation time    -   10) Reduced ICU time    -   11) Faster post-operative recovery    -   12) Reduced hospitalization time    -   13) Reduced rate of complications intraoperative    -   14) Reduced rate of complications postoperative    -   15) Improved and expedited wake-up time from surgery    -   16) Reduced rate of complications due to hypothermia and        hyperthermia    -   17) Reduced health care cost    -   18) Improved patient outcome

Integration of infusion pump with BTT continuous signal can benefitadjustment of infusion rate of some of the most common drugs includingall injectable anesthetics, propofol, phentanyl, midazolam and otherbenzodiazepines, insulin, and vasoactive drugs such as nytric oxide andall vasodilators, phenylephrine and all vasoconstrictors. The level ofcore temperature can also be used to identify effect of drugs and thediagnosis and prognosis of diseases such as Parkinson's, Alzheimer's,and depression. Accordingly FIG. 101 is a diagrammatic view of aninfusion pump 3500 connected to a temperature monitoring system 3502,said temperature monitoring system secured to a living creature 3504.Pump 3500 receives signal from the temperature monitoring system 3502,and said pump 3500 includes an assembly 3506 for delivering drugs to aliving creature 3504.

FIG. 102 shows an exemplary portable remote powering device 3510 coupledto a BTT passive sensing device 3516. The device 3150 includes a screen3528 and antenna 3532, seen held by the hand of a subject and positionedto power the BTT sensing device 3516 located above the eye 3522. BTTsensing device 3516 includes a sensor 3520 and an antenna 3518 foremitting electromagnetic energy. Device 3510 powers passive device 3516with electromagnetic energy 3514, and receives a reflected energy backrepresented as wave 3524 which contains the identification of thesubject being measured and the level of the biologic parameter beingmeasured. By way of illustration, temperature is measured and the levelis displayed on screen 3528. Device 3510 is adapted to provide feed backinformation based on the signal received and the level of the biologicalparameter. In this embodiment the temperature is elevated, causingdevice 3510 to display information for fever, such as antibiotics andanti-fever medications shown in dialog box 3526 of screen 3528. Inaddition, the signal causes the device 3510 to produce a dialogue box3530 for names of pharmacies and doctors associated with the patientidentified by the signal received.

FIG. 103A is a diagrammatic view of another embodiment of a sensingdevice 3540 including a measuring portion 3550 and an arm 3554. The end3552 of arm 3554 ends in holder 3550 and the opposite end 3564 ends in abody of sensing device (not shown). The measuring portion 3550 includesa structure 3542 comprised of a soft compressible insulating materialsuch as polyurethane. Body 3542 has an opening 3544 that houses a wireportion 3548 that terminates in wire 3556 of arm 3544. Body 3542,represented herein by material 3542, has an exposed bottom surface 3560and an exposed side surface shown as 3562. A holder 3550 surroundsmaterial 3542 and connects with arm 3554. The edge 3558 of the holder3550 is preferably located at a distance equal to or no greater than 2mm from the surface 3560, and most preferably equal to or no greaterthan 4 mm from the surface 3560, and even most preferably equal to or nogreater than 6 mm from the surface 3560, said distance represented by adimension shown as 3562. Surface 3560 includes sensor 3546. Thus surface3560 has a combination of a thermistor represented herein by sensor 3546and insulating material such as polyurethane represented by body 3542.

FIG. 103B is a diagrammatic view of a probe cover 3570 for a measuringportion and/or an arm of a sensing device of this invention, such asmeasuring portions and arms of the embodiments of FIG. 86A to FIG. 103A.The probe cover of this invention is essentially soft and thin and it isadapted to fit the dimensions of the sensing devices and supportstructures of this present invention. The probe cover 3570 has one body3576 and two ends 3574 and 3572; one end 3574 is open and adapted toreceive a measuring portion and an opposite end 3572 is closed andadapted to fit a sensor. The open end 3574 has an adhesive surface 3578which is disposed adjacent to the open end 3574, said adhesive surfaceforming an extension of the distal end 3580 of body 3576. The adhesivesurface may include a peel back cover in an extension of body 3576, andwhen in use the peel back cover is removed exposing the adhesivesurface. The adhesive surface 3578 attaches the probe cover to a body ofa sensing device such as body 2002, frame of eyeglasses, headband, andthe like. Any means to attach or firmly secure probe cover to an arm orbody of a sensing device can be used. If the measuring portion is oflarger dimension than arm, the probe cover is adapted to cover and fitboth parts including the measuring portion.

It is understood that any sensor system of the invention can be coupledwith finger-like structure, nose bridge, and other structures describedin FIGS. 86A to 91 or coupled to frames of eyeglasses and head mountedgear described in FIGS. 92 to 100. It is also understood that theeyeglasses of this invention can comprise two separate parts, preferablywith a removably detachable sensor, which becomes the disposable part.The tip of a rod thermometer or rod pulse detection can also house anidentification chip or Radio Frequency identification (RF ID), said tipbeing reusable but only for one patient who is identified by the RF IDor the ID chip, allowing thus full tracibility (of humans and animals)and portability of the sensing device. It is also understood that otherembodiments include using a variety of detecting means housed in thesensing devices of this invention, including evaluating blood flow byconventional means and determining analyte concentration such as byusing laser Doppler positioned at the brain tunnel for determining theconcentration of analytes including glucose. It is also understood thatany of the sensing devices and sensors of this invention can be poweredby solar power or other renewable energy source.

Another embodiment includes stethoscope connected to a PDA, saidstethoscope listening to body sounds such as heart and lung sounds andthe PDA recording on digital file the heart or lung sound, and thencomparing the sound captured with sounds stored in the PDA memory fordetermining the diagnosis of the condition.

The invention also includes methods for determining the usable life orfunction of a sensor based on the thickness of a coating applied to thatsensor. Sensor can be covered in parylene and the thickness of thecovering used for determining the life of the device. By way of example,a temperature sensor is covered with 100 microns thick layer of parylenewhich keeps the sensor functioning for X number of days. A 200 micronsthick layer of parylene keeps then the sensor functioning for 2X numberof days (twice as much) and a 50 microns layer keeps the sensorfunctioning for ½X (half). As the sensor continues to be used the layerof coating gradually dissolves until total dissolution of the coatingexposes the sensor making said sensor inoperative. For example, atemperature sensor ceases to work properly as water and salt from thebody reach the sensor and change the resistance after the parylenecoating is removed.

Another embodiment includes methods and apparatus for detecting bloodflow and diagnosing diseases. The embodiment further includesidentifying changes in blood flow of the brain tunnel area afterapplying drugs locally at the brain tunnel area or systemically by oralor invasive means. The method includes applying, for example, a patchwith acetylcholine to identify autonomic dysfunction and the diagnosisof diabetes, heart disease, vascular disorders and the like. Stepsinclude measuring blood flow, applying or delivering a drug, andmeasuring the blood flow at the same location, such as the brain tunnelarea. If there is a sustained change in blood flow at the brain tunnelarea, then it is determined that function is normal. If after applying adrug the change in blood flow is not sustained it then indicatesautonomic dysfunction.

Another embodiment includes therapy and/or prevention of obesity andreduction of weight through cooling the brain and monitoring thetemperature at the BTT. Placing the subject under anesthesia, whichreduces core temperature, lowers the temperature of the brain. Apreferred step prior to anesthesia is an imaging study such as MagneticResonance Imaging to map and quantify the neuronal activity in thehunger center of the brain or other brain areas. Cooling of the body andof the brain is performed in order to cool the hunger center, andtherefore reducing neuronal firing in the hunger center, and thusnaturally reducing appetite. After the baseline activity is determined,the cooling is performed until core-brain temperature reaches 34 degreesCelsius. When the signal from the temperature sensor, such as the BTT,indicates that level of temperature or other predetermined level, analarm sounds indicating that target temperature was achieved. Dependingon the level of firing of neurons, and the baseline, the anesthesiacontinues on, with extended periods of anesthesia for people with severeobesity so as to shut down the hunger center and appetite, which caneven last 6 months or more. The method and device can include using thearea of the BTT between the eye and eyebrow and to cool this area inorder to directly reduce brain activity. If a center is hyperactive,then cooling can help stabilize firing of neurons. The method andapparatus can also be used for therapy of a variety of neuro-disordersincluding stroke, Alzheimer, Parkinson, depression, and the like.

The invention further includes a memory chip housed in the device with apredetermined amount of memory, which correlates to the life of thedevice. Thus, a chip with capacity for 100 hours of measurements fillsthe chip memory in 100 hours, and after that occurs the sensing devicedoes not work, and preferably a light on the device, such as body 2002or an alarm on the screen of the reading unit informs the user that thelife of the device has expired.

FIG. 104-A is another embodiment showing a diagrammatic view of aspecialized noninvasive internal surface temperature measurement probe3590. The sensor head 3594 of probe 3590 has features of both surfacetemperature measurement and internal temperature measurement. By beingable to detect internal temperature through the sensor head 3594penetrating into the brain tunnel through indenting the skin, the probe3590 measures internal temperature. By touching the surface of the skinwith a non-thermally conductive tip, the sensor head 3594 functions as asurface temperature measuring probe. The probe 3590 is of use only inspecialized areas such as the BTT, which has a concave shape but ofirregular geometry and with some anatomic variations as to the mainentry point of tunnel. There is seen in FIG. 104-A probe 3590 includingmulti-sensor head 3594, straight handle 3600, and curved handle 3606.Sensor head 3594 for temperature measurement comprises an insulatingmaterial 3596 populated with a plurality of thermal sensors 3598, suchas thermistors, thermocouples, silicone, and the like. The insulatingmaterial works as a support structure holding sensors 3598. Preferablythermal sensors 3598 comprise thermistors as per preferred embodimentsof this invention. An array of thermal sensors 3598 is disposed on thesurface of insulating material 3596 of the multi-sensor head 3594. Themulti-sensor head has preferably a convex configuration and specialdimensions. The distance from the tip 3592 of sensor head 3594 to theinferior edge 3602 of the sensor head 3594 is preferably equal to or nogreater than 2.5 mm, and most preferably equal to or no greater than 4.5mm, and even most preferably equal to or no greater than 6.5 mm, andeven much more preferably is a distance equal to or no greater than 5mm. Sensor head 3594 has one or more thermal sensors, and preferably anarray of sensors 3598, each sensor connected with a respective wirerepresented as wire 3604. At the transition between straight handle 3600and curved handle 3606, all wires form the sensors represented herein aswire 3604 join to from a multistrand cable which terminates in wireportion 3610, said wire portion 3610 being connected to a processing anddisplay circuit 3612.

FIG. 104-B is a planar view of sensor head 3594 showing insulatingstructure 3596 populated by an array of sensors 3598. Sensor head 3594has an essentially circular shape. Preferred diameter of sensor head3594 is equal to or no greater than 5.0 mm, and most preferably equal toor no greater than 8.0 mm, and even most preferably equal to or nogreater than 12 mm, and even much more preferably equal to or no greaterthan 20 mm. FIG. 104-C is a diagrammatic view of an embodiment of handheld portable sensing probe 3620 comprised of an essentially flat sensorhead 3616. Probe 3620 includes three parts, a flat sensing tip 3634,also referred to as sensor head; a handle 3630 housing wires 3604 andmultistrand wire 3618; and electronic and display part 3628 which houseschip 3624, battery 3626, and display 3622. Sensor head 3634 includes asensing surface 3616, said sensing surface including an insulatingmaterial 3632 and one or more sensors 3614 disposed along the surface,and having a similar configuration as embodiment of FIG. 104-A.

As seen in FIG. 104-C handle 3630 has preferably a smaller diameter thansensor head 3634. The distance from the tip 3616 of sensor head 3634 tothe inferior edge 3602 of the sensor head 3634 is preferably equal to orno greater than 2.0 mm, and most preferably equal to or no greater than4.0 mm, and even most preferably equal to or no greater than 7.0 mm, andeven much more preferably is a distance equal to or no greater than 5.0mm.

FIG. 104-D is a side perspective view of a boomerang sensor probe 3640including boomerang sensor head 3656 and handle 3650. It is understoodthat handle 3650 can be replaced by arm 2004 or other arms described inthis invention, and any of the sensors heads described herein can beused in a measuring portion of other embodiments. Boomerang sensor head3656 includes two wings 3642 and 3644, but contrary to the conventionalboomerang shape which is essentially flat, the wings 3642 and 3644 havea bulging and essentially convex surface in order to fit with theanatomy of the brain tunnel entry point. Boomerang sensor head 3656further includes a connecting portion 3658 connecting the two wings 3642and 3644, said connecting portion having an essentially bulging andconvex surface 3648, said convex surface 3648 having a much smallerradius than the radius of convex surface of wings 3642 and 3644, thusconnecting portion 3658 is much more bulging than wings 3642 and 3644.Connecting portion 3658 has an essentially protruding configuration andhouses at least one sensor 3646, but preferably houses a plurality ofsensors along its surface, said sensors preferably having also a bulgingconfiguration. The sensors are represented herein as small dots, but toavoid excessive repetition only one number 3646 is used for describingthe plurality of sensors. Sensors 3646 are illustrated as one type ofsensor, such as a thermal sensor, but it is understood that sensorsmeasuring different parameters can be used, and any combination ofsensors are contemplated, for example a sensor head comprising oxygensaturation infrared sensors, electrochemical gas sensors, thermalsensors, and pulse sensors. Each sensor 3646 connects with handle 3650,illustrated herein as wired communication, using wires 3652, whichpreferably become a multistrand cable 3654 in handle 3650. Handle 3650is attached to sensor head 3656 through connecting points 3660 and 3662,located at the end of said handle 3650. Preferred dimensions of probe3640 are consistent with the dimensions and shape of a brain tunnelarea, and more particular the geometry of the area between the eye andthe eyebrow on the upper eyelid and roof of the orbit.

FIG. 104-E is a planar perspective view of a boomerang sensor probe 3640showing the sensing surface 3664 of sensor head 3656, which is thesurface that touches the skin during contact measurements or the surfacethat is viewing the skin for non-contact measurements. The sensingsurface 3664 comprises the connecting bulging portion 3658, and thewings 3642 and 3644, said sensing surface 3662 having one or more sensor3646 on its surface. Connecting points 3660 and 3662 which connect ahandle to the sensor head 3656 are seen as broken lines.

FIG. 104-F is a planar diagrammatic view of boomerang sensor head 3656,and its relation to anatomic structures such as the nose 3672, eyebrow3666, and eye 3674. Wing 3642 which is located below the eyebrow 3666 ispreferably longer than wing 3644 which rests adjacent to the nose 3672.There is also seen the essentially centrally located bulging connectingportion 3658, and its center point 3668, and the impression of thehandle connecting points 3660 and 3662. The boomerang probe 3640 of thisinvention has preferably a tighter angle as compared to a conventionalboomerang configuration. Accordingly the preferred angle 3670 betweenwings 3642 and 3644 is equal to or less than 45 degrees, and preferablyequal to or less than 65 degrees, and most preferably equal to or lessthan 90 degrees. Preferred length of the wing running along the eyebrow3666, illustrated herein as wing 3642, is equal to or less than 35 mm,and preferably equal to or less than 25 mm, and most preferably equal toor less than 20 mm, and even most preferably equal to or less than 14mm, said length going from point 3668 to the edge 3676 of the wing 3642.Preferred width of wing 3642 is equal to or less than 30 mm, andpreferably equal to or less than 20 mm, and most preferably equal to orless than 15 mm, and even most preferably equal to or less than 10 mm.Preferred thickness of wing 3642 is equal to or less than 25 mm, andpreferably equal to or less than 20 mm, and most preferably equal to orless than 15 mm, and even most preferably equal to or less than 10 mm.

Preferred length of the wing running along the nose 3672, illustratedherein as wing 3644, is equal to or less than 33 mm, and preferablyequal to or less than 23 mm, and most preferably equal to or less than18 mm, and even most preferably equal to or less than 12 mm, said lengthgoing from point 3668 to the edge 3678 of the wing 3644. Preferred widthof wing 3644 is equal to or less than 30 mm, and preferably equal to orless than 20 mm, and most preferably equal to or less than 15 mm, andeven most preferably equal to or less than 10 mm. Preferred thickness ofwing 3644 is equal to or less than 25 mm, and preferably equal to orless than 20 mm, and most preferably equal to or less than 15 mm, andeven most preferably equal to or less than 10 mm.

The bulging connecting portion 3658 is the portion adapted to best fitwith the main entry point of the tunnel and is located adjacent to thejunction of the eyebrow 3666 with the bridge of the nose 3672. Preferreddimension or diameter of the bulging connecting portion 3658 is equal toor less than 30 mm, and preferably equal to or less than 25 mm, and mostpreferably equal to or less than 20 mm, and even most preferably equalto or less than 15 mm. Preferred thickness of portion 3658 is equal toor less than 30 mm, and preferably equal to or less than 20 mm, and mostpreferably equal to or less than 15 mm, and even most preferably equalto or less than 10 mm.

Processing circuit, such as processor 3624, screens and selects the mostoptimal signal, depending on the application, from the plurality ofsignals received from the plurality of sensors. In the case of thermalsensors, processing continuously screens and then selects the highesttemperature, which is then reported. One or multiple sensing points canbe checked periodically and one or more signals can be selected anddisplayed. For temperature measurement the thermal sensors are imbeddedin an insulated material shaped to fit into the anatomical and thermalcharacteristics of the BTT pocket for easy placement and optimal heattransfer. Thermal sensor is preferably encapsulated and surrounded witha soft thick, non-conductive, insulating material that will take thecontour/shape of the irregular skin surface to completely seal off anyexternal ambient temperature and also to prevent any skin or tissuesoutside the BTT entrance site from touching the sensor.

Since folds of skin can touch the tip of the sensor head when is pressedagainst the BTT, the sensor head has a unique and specialized dimensionof insulating material surrounding the sensor, which is preferablybetween 3 mm and 5 mm, and most preferably between 2 mm and 7 mm, andeven most preferably between 1.5 mm and 10 mm as seen in FIG. 104-G andFIG. 104-H. FIG. 104-G shows a sensor head 3680 and handle 3682. Thesensor head 3680 has three thermal sensors 3684, 3686 and 3688. Thesensor head 3680 comprises the insulating material 3690 and the threethermal sensors 3684, 3686 and 3688, which are disposed along thesurface of the insulating material 3690. All surfaces of the sensors3684, 3686 and 3688 are surrounded by the insulating material 3690, withthe exception of the surface of the sensor exposed to the environment.The dimension of insulating material 3690 is based on the position of athermal sensor closest to the non-insulating part 3692, illustrated as apart which is made of thermally conductive material or metal such as ahandle 3682. Since sensors 3688 is lower as compared to sensors 3684 and3686, the starting point to determine length or dimension 3694 ofinsulating material 3690 is based on said sensor 3688, the dimension3694 starting at sensor 3688 and ending at non-insulating material 3692.

FIG. 104-H shows a bulging sensor 3696 on the surface of an insulatingmaterial 3690, which terminates in a thermally conductive material 3692.All surfaces of the sensor 3696 is surrounded by the insulating material3690, with the exception of the surface of the sensor exposed to theenvironment or the target area being measured. The dimension ofinsulating material 3690 is based on the position of a thermal sensorclosest to the non-insulating part 3692. Since sensors 3696 is the onlythermal sensor, said sensor 3696 determines the dimension of theinsulating material 3690, the dimension 3694 starting at sensor 3696 andending at non-insulating material 3692. The dimension 3694 is the samefor both embodiments, shown in FIG. 104-G and FIG. 104-H. The sensorinsulation needs to have the described thickness, unlike conventionalsurface temperature probes of the prior art, which needs to be thin. Thereason is because the BTT sensor is pushed into the BTT tunnel openingand the thicker insulation material prevents external ambient influencesand tissues to come in contact with the integrity of the temperaturesensor measuring the opening surface area of the BTT. Insulationmaterial and dimension or length of insulating material as per thepresent invention includes any insulating material around a sensor heador measuring portion, including an insulating holder such as insulatingholder 3550 as shown in FIG. 103A.

The sensing systems of this invention measures, records and/or processesfeedback information for a closed loop system and controlling a seconddevice, such as the infusion pump of FIG. 101 and thus allowing fortherapeutic applications, such as cooling or heating the brain based onthe signal received, or increasing oxygen delivered based on the signalof an oxygen sensor, or increasing the flow of glucose or insulin basedon the signal from a glucose sensor.

It is understood that other configurations of the modular design of theinvention would be apparent to one of ordinary skill in the art. Otherconfigurations using other head mounted gear such as a cap, eyewear, andthe like are contemplated. Those head mounted gear positions and securesthe sensor assembly as a docking device and can measure, record,feedback multiple parameters in a modular design such as pulse oxymetry,heart rate, temperature, and the like.

FIG. 105 illustrates the maintaining of a sensor on the BTT by adhesiveapplied to the body of the support structure. The support structure isapplied on the cheek of the user.

It should be noted that this invention provides not only measurement,recording and processing of a biological parameter such as temperaturebut also includes a device that will house the therapy. By way ofillustration, the modular forehead docking system of this invention caninclude a mechanical holding and positioning structure for a cold or hotelement or substance that is placed on the BTT site for cooling orheating the brain including a thermo-voltaic device such as a Peltierdevice, serpentine for circulating fluids, and the like. The headmounted gear such as the head band of this invention can also be anelectronics structure positioning, powering, and controlling device toheat or cool the BTT site. The module of the sensing head band includescontrolling/processing circuit that can work as a close loop deviceitself for therapy, by having one side a BTT thermometer and the otherside the cold/hot device on the BTT site, providing thus an independentmedical close loop monitoring, controlling and cooling/heating device.

The module of the sensing head band box is also designed to analyze atemperature signal or other biological signal and correlate it to otherpatient data and display other parameters either on the sensing headband device or transmit the information via wire or wireless means toanother host monitor or device. The parameters that the systemcorrelate/calculate/analyze include sleep disorder patterns, Alzheimersyndromes, obesity parameters, calorie burns for weight control,fatigue/drowsiness, ECG/EKG, brain wave patterns, and the like.

1. A clinical temperature detector comprising: an elongated probe havinga proximal end and a distal end, said distal end including a sensingsurface, said sensing surface having insulation and at least one thermalsensor for directly receiving thermal energy from a brain temperaturetunnel on a body surface, said brain temperature tunnel on said bodysurface being located at the supero-medial aspect of the medial canthalarea and the medial half of the upper eyelid, and said at least onethermal sensor having a sensing element surface and said sensing elementsurface being only partially surrounded by said insulation, said sensingelement surface of said at least one thermal sensor directly engagingthe brain temperature tunnel on the body surface in an absence of anyobstruction for measuring temperature from the brain temperature tunnelof the body surface, said measured body surface temperature from thebrain temperature tunnel being conveyed to the proximal end of saidprobe, said insulation being compressible and moldable, said insulationbeing movable with said at least one thermal sensor for maintaining aposition of the insulation on the body surface and said insulationadapting to a shape of the body surface while the at least one thermalsensor measures the body surface temperature from the brain temperaturetunnel by unobstructed contact of the sensing element surface with thebody surface.
 2. The clinical temperature detector according to claim 1,wherein a display device is located at said proximal end of said probe.3. The clinical temperature detector according to claim 1, wherein saidinsulation completely surrounds said at least one thermal sensor exceptfor said sensing element surface.
 4. The clinical temperature detectoraccording to claim 1, wherein said sensing element surface is convex. 5.The clinical temperature detector according to claim 1, wherein saidelongated probe is cylindrical.
 6. The clinical temperature detectoraccording to claim 1, wherein said insulation extends at least 4 mmradially from said at least one thermal sensor.
 7. The clinicaltemperature detector according to claim 1, wherein said measured bodysurface temperature is compared to a thermal signature.
 8. The clinicaltemperature detector according to claim 1, wherein a wire interconnectssaid at least one thermal sensor and an electronic device.
 9. Theclinical temperature detector according to claim 8, wherein said wireexits said probe at a distance spaced from the distal end and theproximal end of the probe.
 10. The clinical temperature detectoraccording to claim 1, wherein the sensor is less than 6 mm in a largestdimension.
 11. The clinical temperature detector according to claim 1,wherein the at least one thermal sensor projects from the insulation.12. The clinical temperature detector according to claim 9, wherein thewire exits said probe at a mid-portion of the probe.
 13. A clinicaltemperature detector comprising: an elongated sensing device having aproximal end and a distal end, said distal end including at least onesensor and an insulating surface, said at least one sensor having asensing element surface and said sensing element surface being onlypartially surrounded by said insulating surface for directly receivingenergy from a brain temperature tunnel on a body surface, said braintemperature tunnel on said body surface being located at thesupero-medial aspect of the medial canthal area and the medial half ofthe upper eyelid, said sensing element surface of said at least onesensor, in an absence of any obstruction, generating a signal indicativeof a measurement, said signal being conveyed towards the proximal end ofsaid probe, said insulating surface being compressible and moldable,said insulation being movable with said at least one sensor formaintaining a position of the insulation on the body surface and saidinsulation adapting to a shape of the body surface while the at leastone sensor generates the signal, and a display device for displayingindicia representative of the signal.
 14. The clinical temperaturedetector according to claim 13, wherein said at least one sensor is atleast one of a temperature sensor, electrochemical sensor, enzymaticsensor, fluorescent sensor and infrared sensor.
 15. The clinicaltemperature detector according to claim 13, wherein said display deviceis part of the sensing device.
 16. The clinical temperature detectoraccording to claim 13, wherein said proximal end of said sensing deviceis a pen.
 17. The clinical temperature detector according to claim 13,wherein said signal is conveyed wirelessly.
 18. A clinical thermometercomprising: an elongated probe having a proximal end and a distal end,said distal end including an insulating sensing surface, said insulatingsensing surface having insulation and a thermal sensor for directlyreceiving thermal energy from a brain temperature tunnel on a bodysurface, said brain temperature tunnel on said body surface beinglocated at the supero-medial aspect of the medial canthal area and themedial half of the upper eyelid, and said thermal sensor having asensing element surface and said sensing element surface being onlypartially surrounded by said insulation, said sensing element surface ofsaid thermal sensor directly engaging the brain temperature tunnel onthe body surface in an absence of any obstruction between the sensingelement surface and the body surface for directly measuring surfacetemperature, said measured surface temperature being conveyed to theproximal end of said probe, said insulation being compressible andmoldable and moving with said thermal sensor while maintaining aposition of the insulation on the body surface and said insulation beingadaptable to a shape of the body surface while the thermal sensormeasures surface temperature by unobstructed contact of the sensingelement surface with the brain temperature tunnel on the body surface.